NEW IMAGE CONVEX CERAPLUS TAPE BORDERED PRESIZED BARRIER
Received Nov 22, 2022 · Event occurred Nov 1, 2022
Report 1119193-2022-00037 · MDR key 15844791
Device
Generic name
New Image Convex Ceraplus Tape Bordered Presized Barrier
Manufacturer
Hollister IncroporatedModel number
11504Catalog number
11504
Lot number
2G192
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Male
- Erythema
- Skin Inflammation/ Irritation
- Erythema
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED FOR TAPE BORDER CAUSING SKIN IRRITATION FOR THIS SKU AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED BASED UPON THE LOT NUMBER PROVIDED AND THE RECORDS WERE FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED SKIN IRRITATION UNDER THE OSTOMY APPLIANCE TAPE BORDER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN OSTOMATE HAS BEEN EXPERIENCING SKIN IRRITATION UNDER THE TAPE BORDER OF HIS NEW IMAGE BARRIER ON AND OFF SINCE HE STARTED USING IT IN 2019. HE REPORTED THAT WHEN HE HAS THE SKIN IRRITATION, HE ALSO EXPERIENCES WATERY EYES. HE STATED HE HAS BEEN TO AN ALLERGIST WHO CONDUCTED PATCH TESTING WHICH WAS NEGATIVE, AND IT COULD NOT BE DETERMINED WHY HE EXPERIENCES THIS RESPONSE. HE REPORTED THAT HE TAKES OVER THE COUNTER ANTIHISTAMINES AND USES A PRESCRIPTIVE STEROID CREAM CALLED FLUOCINONIDE FOR THE OCCASIONAL SKIN IRRITATION. HE STATED HE USES THE CREAM SPARINGLY AND HAS BEEN USING IT ON AND OFF SINCE 2019. HE RECENTLY LEARNED THAT HOLLISTER CARRIES BARRIERS WITHOUT A TAPE BORDER, SO HE CALLED TO REQUEST SAMPLES.