NEW IMAGE
Received Feb 26, 2024 · Event occurred Oct 5, 2023
Report 1119193-2024-00004 · MDR key 18776947
Device
Generic name
2-piece Ostomy Skin Barrier, Ceraplus
Manufacturer
Hollister IncorporatedModel number
11204Catalog number
11204
Lot number
3H012
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Female
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
THE BARRIER WAS NOT SAVED; THEREFORE, A DEVICE EVALUATION COULD NOT TAKE PLACE. A COMPLAINT HISTORY TREND ANALYSIS WAS CONDUCTED FOR SIMILAR COMPLAINTS AND NO ADVERSE TRENDS OBSERVED. A DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED BASED ON THE PRODUCT AND LOT NUMBER AND NO ISSUES WERE IDENTIFIED. THERE WAS NO REPORT OF PRODUCT MALFUNCTION. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED AN ALLERGIC REACTION TO THE ADHESIVE TAPE ON THE NEW IMAGE OSTOMY BARRIER. IT WAS REPORTED THAT SHE WAS HOSPITALIZED FOR 2-3 DAYS TO TREAT THE REACTION. SHE NOW USES A DIFFERENT HOLLISTER BARRIER AND REPORTS IT IS WORKING FINE.