CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH
Received Dec 22, 2022 · Event occurred Dec 13, 2022
Report 1119193-2022-00041 · MDR key 16035823
Device
Generic name
Ceraplus One-piece Flat Drainable Pouch - Flat Barrier, Lock 'n Roll Closure
Manufacturer
Hollister IncroporatedModel number
89301Catalog number
89301
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
49 YR · Female
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. LOT NUMBER NOT PROVIDED SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION UNDER THE OSTOMY BARRIER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT A NEW OSTOMATE EXPERIENCED BLISTERS UNDER THE HOLLISTER OSTOMY FLANGE 3 DAYS AFTER IT WAS APPLIED. IT WAS REPORTED THAT HER SKIN HAS SINCE IMPROVED SINCE USING STEROID CREAM. SHE REPORTS USING A DIFFERENT HOLLISTER BARRIER NOW WITH GOOD RESULTS.