CONVEEN SECURITY SSU 035
Received Apr 21, 2011
Report 3003814961-2011-00003 · MDR key 2065781
Device
Generic name
Male External Catheter Urosheath
Manufacturer
Coloplast A/sModel number
0523501017Catalog number
0523501017
Lot number
2617904
Product problems
- Difficult to Remove
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- Skin Tears
Narrative
Additional Manufacturer Narrative
PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. FOLLOW UP 1: RETURNED PRODUCT WAS TESTED USING A PEEL ADHESION TEST. THE MEASURED VALUES FOR THE TESTING WERE BELOW THE SPECIFICATION. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED FOR WEAK ADHESIVE BUT NOT THE ORIGINALLY REPORTED "STRONG ADHESIVE".
Description of Event or Problem
(B)(6). ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THE PACKAGING ON THE GREEN BAGS WERE DAMAGED-THEY WERE PERFORATED. ALSO, THE ADHESIVE WAS SO STRONG THAT PART OF THE SKIN OF THE PENIS OF THE END USER CAME OFF WHILE TRYING TO REMOVE THE URISHEATH.
Description of Event or Problem
PATIENT IDENTIFIER: (B)(6). DATE OF EVENT: BEST ESTIMATE IS (B)(6) 2011. ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THE PACKAGING ON THE GREEN BAGS WERE DAMAGED-THEY WERE PERFORATED. ALSO, THE ADHESIVE WAS SO STRONG THAT PART OF THE SKIN OF THE PENIS OF THE END USER CAME OFF WHILE TRYING TO REMOVE THE URISHEATH.