BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. A DETAILED INVESTIGATION OR BATCH REVIEW IS NOT REQUIRED AT THIS TIME. IF ADDITIONAL COMPLAINTS OCCUR WITH THIS BATCH AND WITH THE SAME MALFUNCTION CODE, THESE SUBSEQUENT COMPLAINTS SHALL BE ASSESSED AGAINST THE BATCH CRITERIA DATA. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED, BUT NONE HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.
D
Patient 1
COMPLAINT REPORTED BY THE END USER THAT AFTER WEARING THE DEVICE FOR 2-3 DAYS SHE NOTICED PURPLE DISCOLORATION ENCIRCLING STOMA CIRCUMFERENTIALLY EXTENDING OUT ABOUT ONE-EIGHTH OF AN INCH. THERE ARE NO OPENINGS IN THE SKIN, JUST DISCOLORATION. SHE STATES THE ONLY CHANGE IN HER ROUTINE IS THAT SHE HAS A NEW CAREGIVER WHO CUTS THE WAFER INSTEAD OF MOLDING THE OPENING. NO FURTHER DETAILS HAVE BEEN PROVIDED.
N
Patient 1
A BATCH RECORD REVIEW INDICATED NO DISCREPANCIES RELATED TO THE PRODUCT QUALITY OR THIS COMPLAINT. PROCESS CHECKS AND QUALITY CHECKS WERE PERFORMED WITH ACCEPTABLE RESULTS. HOWEVER, A NON-CONFORMANCE (NC) WAS NOTED FOR THE MIX PRODUCT LOT# (5C03629/1002208). FURTHER INVESTIGATION FOUND THIS TO BE RELATED TO A DOCUMENTATION ISSUE WHICH HAS BEEN RESOLVED. THE PRODUCT QUALITY WAS NOT AFFECTED BY THE NC AND HAS BEEN CLOSED. NO FURTHER INVESTIGATION IS REQUIRED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).