Fillable Medical Devices Application 2 (Kinsale Insurance)

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Medical Devices Application 2 (Kinsale Insurance)

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Page 1 of 9
APPLICATION FOR MEDICAL DEVICES INCLUDING DURABLE MEDICAL EQUIPMENT
Instructions to the Applicant – please complete this application in ink and answer all questions completely.
Attach extra sheets as necessary should you run out of space provided. An incomplete or illegible application cannot
be processed. Completion of this application neither binds coverage nor guarantees that a policy will be issued.
Provide a fully completed application, signed and dated by the owner, partner, or officer not earlier than 45 days
before the proposed effective date of coverage.
If a question is not applicable, then state “N/A”.
The following information must be submitted with the completed application:
- Copy of your labels, brochures, marketing and instructions
- Copy of your current products liability insurance declarations page
- Copy of your current financial statement including balance sheet and income statement
- 5-year company loss runs, valued within the last 60 days
GENERAL INFORMATION
Applicant Name:____________________________________________________________________________________________
List of Any Previous Names or Organizations: ____________________________________________________________________
Date Established: __________________________ Website: _______________________________________________
Mailing Address: ___________________________________________________________________________________________
Additional Locations: ________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
Applicant is: Corporation Partnership Joint Venture Not For Profit
Limited Liability Company Individual Other
Audit Contact: _______________________________ Phone Number: _________________________________________
Kinsale Insurance Company
P. O. Box 17008
Richmond, VA 23226
(804) 289-1300
www.kinsaleins.com
Page 2 of 9
Description of Operations: ____________________________________________________________________________________
__________________________________________________________________________________________________________
__________________________________________________________________________________________________________
__________________________________________________________________________________________________________
PRODUCTS AND OPERATIONS
1. Provide the following information for those products, goods and/or services the Applicant wants coverage for. Only those
products, goods and services listed below will be considered for coverage.
Products and Services
Applicant Acts
as a(n)
% of Gross
Receipts
Products and Goods
sold to:
No. of
Years
M W R I MR M W R C O
M: Manufacturer W: Wholesaler R: Retailer I: Importer MR: Manufacturer’s rep.
C: Consumer direct O: Other (describe):_________________________________________________________________
2. Annual Sales
Sales – United States
Sales – Foreign
Total Sales
Upcoming Year
________________________
________________________
________________________
Current Year
________________________
________________________
________________________
First Prior Year
________________________
________________________
________________________
Second Prior Year
________________________
________________________
________________________
Third Prior Year
________________________
________________________
________________________
Fourth Prior Year
________________________
________________________
________________________
3. Have you discontinued or are you considering discontinuing any product or service listed above:
If Yes, provide details. _________________________________________________________________________
______________________________________________________________________________________________________________
Yes No
4. Is the Applicant presently considering introducing any new product or service not listed above?
If Yes, provide details. _________________________________________________________________________
Yes No
Page 3 of 9
5. Do you directly import any products or component parts?
If so, please list the products and provide the corresponding
percentage of total sales, manufacturer and countries of origin.
_____________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
Yes No
6. Who designs your products? ________________________________________________________________
7. Are your designs reviewed, tested and verified by others?
Yes No
8. Are all warning labels, instructions, operating manuals, warranties and advertising material reviewed by
outside counsel?
Yes No
9. Does your product meet applicable government and/or industry standards?
Yes No
10. Have you, any of your products or any of your component parts ever been the subject of any investigation,
enforcement action, or notice of violation of any kind by any governmental, administrative or regulatory
body including the FDA or FTC?
If Yes, please provide details. _________________________________________
________________________________________________________________________________________
Yes No
11. Do you have a formal written products recall procedure?
Yes No
12. Have you voluntarily or involuntarily recalled, or are you considering recalling, any known or suspected
defective products from the market? If yes, provide details: __________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
Yes No
13. Do you comply with Good Manufacturing Practices (GMP)?
Yes No
14. Are you a member of any trade organization?
If yes, please list:
______________________________________
________________________________________________________________________________________
Yes No
MANUFACTURERS
1. Do you manufacture, package or sterilize products for others under their name or label?
If so, provide details.__________________________________________________________________________
________________________________________________________________________________________
Yes No
2. Do you maintain formal written quality control and testing procedures?
Yes No
3. How long are quality control and testing records kept:
4. Do you maintain the following records:
i. When and where your product was manufactured?
ii. To whom your product was sold and the date of sale?
iii. Who supplied the materials going into the product?
iv. Changes in design?
v. Changes in advertising material?
How long do you maintain these records?
Yes No
Yes No
Yes No
Yes No
Yes No
5. Do you obtain Certificates of Product Liability Insurance from each of your suppliers?
i. Are you listed as an Additional Insured under each supplier’s Product Liability Insurance?
Yes No
Yes No
6. Have you attained ISO 9000, QS 9000 or similar Certification?
Yes No
DISTRIBUTORS
1. Do you distribute products under your name or label? Yes No
2. If you contract the manufacturing of your product to others, do you have a formal written agreement with
your subcontractors?
Yes No
3. Are you a manufacturer’s representative?
If yes, attach the written agreement between you and the manufacturer.
Yes No
Page 4 of 9
4. Do you obtain Certificates of Insurance from all manufacturers/suppliers evidencing Product Liability
insurance?
i. Are you included as an Additional Insured-Vendor under each manufacturer’s/supplier’s Product
Liability insurance?
ii. What are the minimum limits of insurance required? _____________________
Yes No
Yes No
5. Please list each manufacturer and their location:
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
6. Percentage of equipment sold or leased/rented which is physician prescribed: _______%
7. Do you maintain the following records:
i. When and where your product was manufactured?
ii. To whom your product was sold and the date of sale?
iii. Who manufactured the product?
vi. Changes in design?
vii. Changes in advertising material?
How long do you maintain these records? _____________________
Yes No
Yes No
Yes No
Yes No
Yes No
MEDICAL DEVICES
1. Do you buy, sell or rent used equipment?
i. Percentage of total operations______ %
ii. Do you recondition/repair prior to resale?
Yes No
Yes No
2. Do you repair or install your products?
i. Are you or your employees factory trained?
ii. Is maintenance performed and documented according to the manufacturer’s guidelines?
Yes No
Yes No
Yes No
3. Do you subcontract repair or installation operations?
i. Do you obtain Certificates of Liability from your subcontractors?
ii. What are the minimum limits of insurance required? _______________
Yes No
Yes No
4. Are Material Data Safety Sheets and Scheduled Maintenance Procedures issued to each customer?
Yes No
5. Do you require all sales and service personnel to participate in a formal program that instructs them on all
applicable company policies, procedures and product training?
Yes No
6. When was your last FDA inspection? _______________ Were you issued a FDA 483 form?
If yes, please attach the form and your response.
Yes No
7. Are any of your products currently being used in a clinical trial or any other tests involving human subjects?
If yes, explain.______________________________________________________________________________
________________________________________________________________________________________
Yes No
Page 5 of 9
8. Do you promote your products for any off-label use?
If yes, explain.______________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
Yes No
9. Staff
Staff: Full Time Part Time Contracted
MD/Physicians
Service Technicians
Physical Therapists
Respiratory Therapists
Nurses
Pharmacists
Sales Reps
Other (specify)
Check the hiring procedures that apply or are performed:
Criminal Background Checks
Drug, alcohol and sexual abuse screening or testing
Verification of certification or professional licensing
Reference Checks
Questioning of employees in their previous involvement as defendants in professional malpractice litigation.
10. Indicate Product Revenues:
Sales
Rental
FDA Class I:
FDA Class II:
FDA Class III:
Page 6 of 9
Indicate the following %:
Implantable Devices: Silicone: Latex:
Durable Medical
Equipment:
Orthopedic/Prosthetic:
Dental:
Pediatric:
Medical Instruments:
11.
Durable Medical Equipment:
i. Sales/Rentals:
ADL Device ____________ % Apnea Monitor ____________ %
Beds, Walkers, Crutches ____________ % Braces ____________ %
CPAP Device ____________ % CPM Device ____________ %
Diabetic Supplies ____________ % Defibrillators ____________ %
Disposables ____________ % Enteral Therapy ____________ %
Latex Gloves (powder) ____________ % Latex Gloves (
powder free) ____________ %
LAL Mattress ____________ % Lift Chairs ____________ %
Motorized Scooters ____________ % Motorized Wheelchairs ____________ %
Nebulizers ____________ % Orthotics ____________ %
Oxygen Concentrators ____________ % Oxygen Cylinder ____________ %
Parenteral Therapy ____________ % Safety Bar/Harness ____________ %
Stair/Ceiling Lifts ____________ % TENS Unit ____________ %
Ventilators ____________ % Wheelchairs ____________ %
Wheelchair Lifts ____________ % Other (describe) ____________ %
___________________________________
ii. Installation:
Ceiling Lifts ____________ % Elevators ____________ %
Grab Bars ____________ % Ramps ____________ %
Stair Lifts ____________ % Wheelchair Lifts ____________ %
Wheelchair Lifts in Autos ____________ % Other Installation ____________ %
LOSS HISTORY
1. How many adverse events have been reported to you and/or the FDA concerning your products in the last 5 years?
Please provide details. _______________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
Page 7 of 9
2. How many customer complaints have you received concerning your products in the last 5 years?
Please provide details.
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
3. Is any person or organization proposed for this insurance aware of any fact, incident, circumstance,
situation, condition, defect or suspected defect which may result in a claim, such that would fall under the
proposed insurance?
Yes No
If yes, please provide details.
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
4. Has any claim been made against any person or organization proposed for this insurance during the last five
(5) years?
Yes No
If yes, please provide five (5) year loss history for all claims, including any predecessor. Attach a description of any loss
greater than $10,000.
Year
No. of Claims
Total Amounts Paid
Amounts Reserved
Total Incurred
Date of Loss Info.
INSURANCE INFORMATION
1. Has any insurer declined, canceled, or nonrenewed any General Liability, Products Liability or similar
insurance on behalf of any person or organization proposed for this insurance?
Yes No
If yes, please provide details.
___________________________________________________________________________________
2. Provide the following insurance information for the prior five (5) years:
Year
Limits of Liability
Deductible/SIR
Premium
Effective Dates
Retroactive Date
3. Indicate the limits of liability and deductible requested:
i. General Liability Limits - $__________________/$_________________ Deductible - $______________
ii. Products Liability Limits - $__________________/$_________________ Deductible -$______________
iii. Professional Liability Limits - $__________________/$_________________ Deductible -$______________
Page 8 of 9
FRAUD WARNING
NOTICE TO ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, CONNECTICUT, DELAWARE, GEORGIA, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS,
MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NORTH
CAROLINA, NORTH DAKOTA, OREGON, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TEXAS, UTAH, VERMONT, WASHINGTON, WEST VIRGINIA,
WISCONSIN, AND WYOMING APPLICANTS: In some states, any person who knowingly, and with intent to defraud any insurance company or other
person, files an application for insurance or statement of claim containing any materially false information, or, for the purpose of misleading, conceals
information concerning any fact material thereto, may commit a fraudulent insurance act which is a crime in many states.
NOTICE TO COLORADO APPLICANTS: It is unlawful to knowingly provide false, incomplete or misleading facts or information to an insurance company for
the purpose of defrauding or attempting to defraud the company. Penalties may include imprisonment, fines, denial of insurance and civil damages. Any
insurance company or agent of an insurance company who knowingly provides false, incomplete or misleading facts or information to a policy holder or
claimant for the purpose of defrauding or attempting to defraud the policyholder or claiming with regard to a settlement or award payable for insurance
proceeds shall be reported to the Colorado Division of Insurance within the Department of Regulatory Agencies.
NOTICE TO DISTRICT OF COLUMBIA APPLICANTS: WARNING: It is a crime to provide false or misleading information to an insurer for the purpose of
defrauding the insurer or any other person. Penalties include imprisonment and/or fines. In addition, an insurer may deny insurance benefits if false
information materially related to a claim was provided by the applicant.
NOTICE TO FLORIDA APPLICANTS: Any person who knowingly and with intent to injure, defraud or deceive any insurance company files a statement of
claim containing any false, incomplete or misleading information is guilty of a felony of the third degree.
NOTICE TO HAWAII APPLICANTS: For your protection, Hawaii law requires you to be informed that presenting a fraudulent claim for payment of a loss or
benefit is a crime punishable by fines or imprisonment, or both.
NOTICE TO KENTUCKY APPLICANTS: Any person who knowingly and with intent to defraud any insurance company or other person files an application for
insurance containing any materially false information or conceals, for the purpose of misleading, information concerning any fact material thereto
commits a fraudulent insurance act, which is a crime.
NOTICE TO LOUISIANA APPLICANTS: Any person who knowingly presents a false or fraudulent claim for payment of a loss or benefit or knowingly
presents false information in an application for insurance is guilty of a crime and may be subject to fines and confinement in prison.
NOTICE TO MAINE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the purpose
of defrauding the company. Penalties may include imprisonment, fines, or denial of insurance benefits.
NOTICE TO NEW JERSEY APPLICANTS: Any person who includes any false or misleading information on an application for an insurance policy is subject to
criminal and civil penalties.
NOTICE TO NEW MEXICO APPLICANTS: Any person who knowingly presents a false or fraudulent claim for payment of a loss or benefit or knowingly
presents false information in an application for insurance is guilty of a crime and may be subject to civil fines and criminal penalties.
NOTICE TO NEW YORK APPLICANTS: Any person who knowingly and with intent to defraud an insurance company or other person files an application for
insurance or statement of claim containing any materially false information, or conceals, for the purpose of misleading, information concerning any fact
material thereto, commits a fraudulent insurance act, which is a crime and shall also be subject to a civil penalty not to exceed $5,000 and the stated value
of the claim for each such violation.
NOTICE TO OHIO APPLICANTS: Any person who, with intent to defraud or knowing that he/she is facilitating a fraud against an insurer, submits an
application or files a claim containing a false or deceptive statement is guilty of insurance fraud.
NOTICE TO OKLAHOMA APPLICANTS: WARNING: Any person who knowingly, and with intent to injure, defraud or deceive any insurer, makes a any claim
for the proceeds of an insurance policy containing any false, incomplete or misleading information is guilty of a felony.
NOTICE TO PENNSYLVANIA APPLICANTS: Any person who knowingly and with intent to defraud any insurance company, or other person, files an
application for insurance or statement of a claim containing any materially false information or conceals for the purpose of misleading, information
concerning any fact material thereto commits a fraudulent insurance act, which is a crime and subjects the person to criminal and civil penalties.
NOTICE TO TENNESSEE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the
purpose of defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.
NOTICE TO VIRGINIA APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the purpose
of defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.
The Applicant acknowledges that the answers provided herein are based on a reasonable inquiry and/or investigation. The Applicant warrants that the
above statements and particulars together with any attached or appended documents are true and complete and do not misrepresent, misstate or
omit any material facts.
Page 9 of 9
The Applicant agrees to notify us of any material changes in the answers to the questions on this questionnaire which may arise prior to the effective
date of any policy issued pursuant to this questionnaire and the Applicant understands that any outstanding quotations may be modified or withdrawn
based upon such changes at our sole discretion. Completion of this form does not bind coverage. Applicant’s acceptance of the company’s quotation is
required prior to binding coverage and policy issuance. All written statements and materials furnished to the company in conjunction with this
application are hereby incorporated by reference into this application and made a part of this application.
Applicant:
_____________________________________
Title:
________________________________
FEIN #:
_____________________________________
Applicant’s Signature:
___________________________
Date:
________________________________
Agent / Broker Name:
______________________________________________________________________
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Medical Devices Application 2 (Kinsale Insurance)

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Completed 20 July 2020

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