NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER
Received May 18, 2022 · Event occurred Apr 17, 2022
Report 1119193-2022-00017 · MDR key 14428816
Device
Generic name
New Image Soft Convex Ceraplus Cut To Fit Barrier
Manufacturer
Hollister IncroporatedCatalog number
11704
Lot number
2B192
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
63 YR · Female
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN END USER STARTED DEVELOPING A RASH AND OOZING UNDER THE HOLLISTER OSTOMY SKIN BARRIER AFTER USING THESE PRODUCTS FOR 5 MONTHS. SHE REPORTED THAT THE RASH SPREAD TO MOST OF HER BODY. SHE STATED HER DOCTOR PRESCRIBED TRIAMCINOLONE OINTMENT AND KEFLEX FOR 7 DAYS. SHE SAID THE RASH HAD NOT FULLY RESOLVED SO SHE WAS PLACED ON ORAL PREDNISONE AND WILL SEE A WOCN. SHE HAS SINCE SWITCHED TO A DIFFERENT HOLLISTER OSTOMY BARRIER AND SHE REPORTED IT DOES NOT SEEM TO CAUSE THIS REACTION.
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 OSTOMY BARRIER CANNOT BE DETERMINED.