MDR event

Additional Manufacturer Narrative

BRAND NAME: OSTOMY-UNKNOWN WAFER, COMMON DEVICE NAME: PROTECTOR, OSTOMY, PRODUCT CODE: EXE, MANUFACTURER: CONVATEC INC. (B)(4). MODEL#: OSTOMY-UNKNOWN WAFER. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOTHING HAS BEEN RECEIVED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

IT WAS REPORTED BY THE END USER THAT SHE WAS PROVIDED CONVATEC CUT-TO-FIT WAFERS BY HER HOME CARE NURSE SOMETIME IN 2006 OR 2007 AND WHEN SHE CUT THEM, THE CUT EDGES FELT SHARP. THE END USER REPORTS SHE HAD A SMALL AMOUNT OF BLEEDING FROM HER STOMA AND THINKS IT WAS CAUSED BY THE SHARP EDGE. THE END USER CHANGED OUT THE WAFERS TO LARGER MOLDABLE ONES AND THE BLEEDING RESOLVED AND HAS NOT RECURRED. NO FURTHER HARM WAS REPORTED BY THE PATIENT. NO PICTURES WERE AVAILABLE AND NO FURTHER DETAILS HAVE BEEN PROVIDED.