PREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY POUCHING SYSTEM
Received Apr 12, 2022 · Event occurred Jun 1, 2021
Report 1119193-2022-00009 · MDR key 14085935
Device
Generic name
Premier Convex Flextend Tape Bordered Urostomy Pouching System
Manufacturer
Hollister IncroporatedCatalog number
84798
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Male
- Skin Erosion
- Tissue Breakdown
- Skin Erosion
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED FOR SKIN IRRITATION OR PRESSURE INJURY. SINCE LOT NUMBER NOT PROVIDED DHR REVIEW NOT POSSIBLE. NO EVIDENCE THAT THIS A IS LOT-SPECIFIC ISSUE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED PERISTOMAL WOUNDS CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2021 AN END USER WITH A UROSTOMY STARTED EXPERIENCING PERISTOMAL WOUNDS UNDER THE HOLLISTER PREMIER CONVEX BARRIER AT ABOUT THE SAME TIME HE STARTED USING THE NEW HOPE HERNIA BELT WITH HIS HOLLISTER APPLIANCE. THE END USER REPORTED THAT HE NEEDED TO USE A CONVEX BARRIER AND THE HERNIA BELT IN ORDER TO PREVENT URINE LEAKAGE DUE TO MULTIPLE ABDOMINAL HERNIAS. THE END USER REPORTED THAT HE IS NOW SEEING A WOCN REGULARLY WHO IS USING A CAUTERY STICK TO CAUTERIZE AREAS OF THE WOUND THAT ARE BLEEDING AND IS USING SILVER ALGINATE WOUND DRESSINGS ON THE PERISTOMAL WOUNDS. THE END USER REPORTED THAT HE DOES NOT BELIEVE THE HOLLISTER APPLIANCE IS MALFUNCTIONING OR THAT THIS IS RELATED TO ANY PARTICULAR LOT OF APPLIANCE. HOLLISTER IS SENDING OTHER OSTOMY PRODUCTS FOR HIM TO TRIAL.