NEW IMAGE FLEXTEND CUT TO FIT TAPE BORDERED BARRIER
Received Jun 22, 2021 · Event occurred Oct 1, 2020
Report 1119193-2021-00017 · MDR key 12042011
Device
Generic name
New Image Flextend Cut To Fit Tape Bordered Barrier
Manufacturer
Hollister IncorporatedCatalog number
14603
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
THE LOT NUMBER IS NOT KNOWN SO THE DEVICE HISTORY RECORD REVIEW IS NOT POSSIBLE. THE DEVICE NOT SAVED FOR RETURN SO DEVICE EVALUATION NOT POSSIBLE. THE TREND ANALYSIS CONDUCTED SHOWED NO ADVERSE TRENDS. ESTIMATES USED FOR PATIENT'S WEIGHT BECAUSE ACTUAL WEIGHT NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION UNDER THE TAPE BORDER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER, WHO HAD STOMA SURGERY IN (B)(6) 2019 STARTED DEVELOPING SKIN IRRITATION UNDER THE TAPE BORDER OF THE HOLLISTER OSTOMY APPLIANCE IN (B)(6) 2020. THE SKIN WAS PAINFUL, BLEEDING AND WEEPY. HE WENT TO A WOCN WHO PRESCRIBED HIM NYSTATIN POWDER AND HIS FAMILY DOCTOR WHO PRESCRIBED HIM TWO 3-DAY COURSES OF AN ORAL STEROID AND NYSTATIN CREAM. THE ORAL STEROIDS HELPED CLEAR UP THE AREA BUT THE IRRITATION UNDER THE TAPE BORDER RETURNED ONCE HE STOPPED. HE NOW USES AN OTC SKIN CARE PRODUCT WHICH IS HELPING A LITTLE. HE WILL TRY SOME OTHER OSTOMY BARRIER SAMPLES THAT HOLLISTER WILL SEND HIM TO SEE IF THAT RESOLVES HIS SKIN IRRITATION.