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Section A: Contact Information

 


Reported By:
*Required Fields
First Name*

Last Name*

Title

Dept

Phone/Ext#
/
Fax#

Email*

Facility-Distributor

Street Address

City

State/Province

Zip/Postal

Country

Date
(e.g. 01-20-2006)

- -

Additional Contact Info.

Surgeon RN Other

Facility

Name/Title

Street

City

State/Province

Zip/Postal

Country

Phone/Ext#
  /  
Fax#

Email



Section B: Description of Complaint - Incident

 

Complaint – Incident Description:

Procedure

Description

Type of surgical intervention, if performed

Patient/User Outcome: (check all that apply)

No injury

Injury required admission

Prolonged hospitalization - how long?

Life threatening

Death

Other

Patient Status (if known)

Date of Incident / Surgery
(ex. 01-20-2003)

- -

 Product Description:

Product Catalogue #

Serial/Lot #

Product Name

Will product be returned?
(Return product/packaging/Label material, if available)

Yes No
If no, why not?

If yes, date to be returned? (ex. 01-20-2006)
- -
Product Is


  actual product from incident - complaint?

Yes No
  from same serial-lot#?

Yes No
  other


Did incident-complaint occur during Pre-op or Post-op testing?   


Yes  No
Was product decontaminated?
Yes No
What decontamination method was used?

Certificate packaged with product?
  Yes No
Date (ex. 01-20-2003)
- -

 




 
 
     
     
     
 
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