PREMIER SOFT CONVEX TAPE BORDERED POUCH
Received May 24, 2022 · Event occurred Feb 17, 2022
Report 1119193-2022-00018 · MDR key 14490174
Device
Generic name
Premier Soft Convex Tape Bordered Pouch
Manufacturer
Hollister IncroporatedCatalog number
8678
Lot number
2C072
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR · Male
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN END USER STARTED DEVELOPING A SKIN RASH WITH WEEPINESS UNDER THE TAPE BORDER OF HIS HOLLISTER OSTOMY APPLIANCE. HE REPORTED THAT HE HAS HAD HIS STOMA FOR 6 YEARS AND HAD BEEN USING THIS APPLIANCE THE WHOLE TIME. HE REPORTED THAT THIS SKIN RASH STARTED 2-3 MONTHS AGO AND HAS HAD A SKIN BIOPSY, BEEN ON ORAL PREDNISONE, TOPICAL HYDROCORTISONE, AND RECEIVED KENALOG & CONSENTYX INJECTIONS TO TREAT THIS AND NONE OF IT HAS WORKED. HE IS NOW CALLING HOLLISTER FOR SUGGESTIONS. HOLLISTER WILL SEND HIM SAMPLES OF PRODUCTS WITHOUT TAPE BORDERS FOR HIM TO TRY.
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY RECORDS REVIEWED FOR THE LOT NUMBER PROVIDED AND FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED REACTION TO THE TAPE BORDER OF THE OSTOMY APPLIANCE CANNOT BE DETERMINED.