ESTEEM+

Description of Event or Problem

THE END USER REPORTED THAT THE FRANGIBLE ATTACHMENT HOLDING THE UROSTOMY TAP CLOSURE PIECE OF THE COMPANY'S KNOWN UROSTOMY POUCH CLOSURE HAD BEEN CUTTING AND SCRAPING HER RIGHT LEG. SHE STATED IT WAS TOO HARD AND PROTRUDING AND KEPT RUBBING AGAINST THE SAME AREA ON HER LEG CAUSING THE INJURY. SHE DENIED ANY BLEEDING, BUT NOTED REDDENED SCRAPED AREAS WITH INTACT SKIN. SHE STATED THAT IT DID NOT NEED MEDICAL TREATMENT OR BANDAGE. SHE TRIALED THIS PRODUCT AND THIS WAS THE FIRST TIME THAT SHE HAD WORN IT. IT HAD BEEN ON FOR ONE DAY. NO PHOTO IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

A2: AGE AT THE TIME OF EVENT: 61 YEARS. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: 1049092. THIRD PARTY MANUFACTURING SITE (FOR LIFE): 3003759552.