MODERMAFLEX CONVEX UROSTOMY POUCH WITH CUT TO FIT BARRIER
Received Oct 26, 2021 · Event occurred Oct 18, 2021
Report 1119193-2021-00034 · MDR key 12699188
Device
Generic name
Modermaflex Convex Urostomy Pouch With Cut To Fit Barrier
Manufacturer
Hollister IncroporatedCatalog number
2979025
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR
- Rash
- Rash
Narrative
Additional Manufacturer Narrative
THIS HOLLISTER SKU, 2979025, WHICH IS NOT SOLD IN THE US, IS EQUIVALENT TO HOLLISTER PREMIER UROSTOMY POUCH, SKU 84794, WHICH IS SOLD IN THE US. SINCE THE LOT NUMBER WAS NOT PROVIDED, A DHR REVIEW IS NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION IS NOT POSSIBLE. PATIENT'S AGE, GENDER, WEIGHT AND RACE NOT KNOWN. THE PATIENT IS NOW USING A HOLLISTER UROSTOMY POUCH THAT DOES NOT HAVE A TAPE BORDER AND IS NOT EXPERIENCING A SKIN REACTION.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT IN A CLINIC USED CORTISONE TO CLEAR UP A RASH UNDER THE TAPE BORDER OF THE HOLLISTER OSTOMY BARRIER. WHEN THE PATIENT STARTED USING THE HOLLISTER BARRIER WITH A TAPE BORDER AGAIN, THE RASH RETURNED WITHIN 24 HOURS. THE CLINICIAN SAYS THIS IS A CONTACT ALLERGY TO THE ADHESIVE.