PRODUCT LIABILITY APPLICATION FOR MEDICAL PRODUCTS MANUFACTURERS

 

Applicant Instructions:  Answer all questions.  If answer is “none” please state “none” or “n/a”.  Owner, partner or officer must sign application.  This application will be attached to and become part of any insurance policy issued.

 

1.     APPLICANT

A.    Full name of all entities to be insured:______________________________________________________

B.    Principal mailing address:______________________________________________________________

C.    Phone#:_____________________________                         Fax#:______________________________

D.    FEIN: _______________________________ Website: _____________________________________

E.     Contact Name: _________________________________ Email: ______________________________

F.     r Individual     r Partnership     r Corporation     r Limited Partnership     r LLC     r Other

G.    Years in business using current name: ___________________________________________________

H.    Are you a subsidiary of another entity or do you have any subsidiaries?            r Yes                 r No

        __________________________________ If yes, please explain_______________________________________________________________________________

I.       Proposed effective date for this insurance: _________________________________________________

 

2.     PRODUCTS

A.    List each product you sell, manufacture or distribute.  For each product, list whether you are

        (M) Manufacturer, (I) Importer, (W) Wholesaler, (MR) Manufacturers Representative, (D) Distributor. 

 

B.    List who you sell to:  (W) Wholesaler, (MR) Manufacturers Representative, (R) Retailer, (E) Direct to End User (consumer).  If you seek coverage for multiple products, please attach list including below requested sale information for each product.

 

                           Product                                            Gross Sales                You Are                You Sell To

                                                                                    (Est. This Yr.)

               ________________________                _______________         ____________      _______________

               ________________________                _______________         ____________      _______________

               ________________________                _______________         ____________      _______________

               ________________________                _______________         ____________      _______________

 

C.    Gross Sales:  Last Year_______________________                     Preceding Year       _______________

                                                                                                                                         

D.    Have you discontinued or are you considering discontinuing any product to be covered by this insurance?                                                                                                                    r Yes                          r No

        If Yes, please describe fully:___________________________________________________________


 

E.     With respect to each product

1.     Do you manufacture completed products?                                                            r Yes              r No

2.     Do you import component parts?                                                                         r Yes              r No

3.     Do you export products or have foreign operations?                                             r Yes              r No

4.     Are any of your products subject to regulation by any government agency?           r Yes              r No

      Explain any “yes” answer to 2, 3 or 4 above:____________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

 

F.     Do you intend to manufacture/distribute any new product in the next 12 months?          r Yes              r No

  If yes, please provide new product documentation with this application

 

G.    Do you provide a “warranty” on your products?                                                          r Yes              r No

        If yes, please attach sample.

 

H.    Do you service, maintain or repair any products?                                                         r Yes              r No

        If yes, please explain and attach copies of contracts if applicable:________________________________

        _________________________________________________________________________________

 

I.       Do you give or obtain hold harmless, indemnity agreements or certificates of insurance from your

        dealers or suppliers?                                                                                                  r Yes              r No

        If yes, please attach copies.

 

3.     PROCESSING AND QUALITY CONTROL

A.    Processing

1.     Do others manufacture, assemble, package or install products under

your name or label?                                                                                             r Yes              r No

 

2.     Do you manufacture, assemble, package or install products for others

      under their name or label?                                                                                    r Yes              r No

      Please explain any “yes” answer to A.1 or 2 above:_______________________________________

_________________________________________________________________________________   

 

B.    Quality control and record keeping

1.     Are written quality control and testing procedures followed?     r Yes                  r No              

2.     How long are quality control and testing records kept? __________________________________       

3.     Do your records indicate when each product unit is manufactured?                       r Yes              r No

4.     Do your records show to whom and when each unit is sold?    r Yes                  r No

5.     Do your records show suppliers of component parts used in products?           r Yes                    r No

6.     Do you require certificates evidencing Products Liability Insurance from

      suppliers?                                                                                                            r Yes              r No

                     Please explain any “no” answer to B.1 - 6 above:_________________________________________

               _________________________________________________________________________________


 

4.     LOSS PREVENTION, LOSS CONTROL, CLAIM DEFENSE

 

A.    Who designs the products?_____________________________________________________________

 

B.    Who owns the patents? ______________________________________________________________

 

C.    Are designs reviewed, tested and verified by others?                                                    r Yes              r No

      If yes, by whom?____________________________________________________________________

 

D.    Do you maintain records of changes in designs, advertisements and

sales brochures?                                                                                                          r Yes              r No

 

E.     Does legal counsel, relative to product safety or intended use, review all instructions, operating manuals, warnings, advertisements and warranties periodically?                                                                 r Yes              r No

 

F.     Are your products designed, tested, labeled and manufactured to meet or exceed all applicable government and industry standards?                                                                                                      r Yes              r No

 

G.    List your memberships in any industry product-standard organizations:_____________________________

        _________________________________________________________________________________   

 

H.    Do you have a specific written program to withdraw known or suspected defective

products from the market?                                                                                           r Yes              r No

 

I.       Have you ever recalled or are you considering recalling any known or

      suspected defective products from the market?                                                            r Yes              r No

 

J.    Do you sell products direct to consumer or end – user?                                                r Yes              r No

 

K.  Do you maintain purchase records of components from other manufacturers used in your products?

                                                                                                                                         r Yes              r No

 

              

5.     CLAIMS HISTORY (please attach prior carrier company loss runs)

A.    Please list all claims during the past five (5) years:

 

              Policy Period                             Total Amounts Paid                        Total Amounts Reserved

        ___________________                   __________________                      _____________________

        ___________________                   __________________                      _____________________

        ___________________                   __________________                      _____________________                 ___________________                   __________________                      _____________________

 

B.    Are you aware of any incidents that may give rise to future claims?   r Yes                  r No

      If yes, please describe:________________________________________________________________

      _________________________________________________________________________________


 

6.     INSURANCE

 

A.    Please indicate prior insurance carried:

 

        Year                      Company                      Deductible/SIR               Limit Carried              Premium

___________       ____________________      ________________         _______________       _________   

___________       ____________________      ________________         _______________       _________

___________       ____________________      ________________         _______________       _________

___________       ____________________      ________________         _______________       _________

 

B.    Is your current coverage r Claims Made or r Occurrence

      If “Claims Made” please provide Retro Date:

 

C.    Insurance requested:

1.     Limit of Liability:______________________________________

2.     SIR (self insured retention): $10,000 SIR to be included, higher SIR available ________________

3.     Include General Liability Coverage in the quote?  r Yes    r No

 

D.    Has an insurer ever canceled or refused to renew or has their been any lapse in coverage in your Products Liability Insurance?                                                                                             r Yes           r No

              If yes, please explain:_________________________________________________________________

              

              

 

 

APPLICANT WARRANTY:  I warrant that the information contained herein is true and that the information provided shall be the basis of the Policy of Insurance and shall be deemed incorporated into the policy.

 

I further acknowledge that signing this application does not bind the applicant or any Insuring Company or Agency to complete this Insurance.

 

All instruction manuals, operating manuals, warnings, advertisements and warranty statements must accompany this application.

 

INCOMPLETE APPLICATIONS WILL BE REJECTED

 

 

SIGNATURE OF APPLICANT________________________________________       DATE______________

 

TITLE________________________________________________________                                                         

 

 

Any person who knowingly 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 act, which is a crime and punishable by civil penalties in certain jurisdictions.