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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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