NEW IMAGE CONVEX PRESIZED OSTOMY BARRIER
Received Dec 14, 2021 · Event occurred Dec 1, 2021
Report 1119193-2021-00038 · MDR key 13002976
Device
Generic name
New Image Convex Presized Ostomy Barrier
Manufacturer
Hollister IncroporatedCatalog number
14905
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR · Female
- Itching Sensation
- Itching Sensation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. SINCE LOT NUMBER NOT PROVIDED DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. PATIENT'S WEIGHT AND RACE NOT KNOWN. ROOT CAUSE OF REPORTED ITCHY AND BLEEDING SKIN UNDER THE BARRIER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WAS USING THE HOLLISTER NEW IMAGE OSTOMY BARRIER AND HER SKIN STARTED ITCHING UNDER THE BARRIER; SHE WOULD SCRATCH IT AND IT WOULD START BLEEDING. THE DOCTOR PRESCRIBED NYSTATIN. THAT DID NOT HELP. SHE WILL BE TRIALING A DIFFERENT FORMULATION OF HOLLISTER'S OSTOMY BARRIERS TO SEE IF THAT MAKES A DIFFERENCE.
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. SINCE LOT NUMBER NOT PROVIDED DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. PATIENT'S WEIGHT AND RACE NOT KNOWN. ROOT CAUSE OF REPORTED ITCHY AND BLEEDING SKIN UNDER THE BARRIER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WAS USING THE HOLLISTER NEW IMAGE OSTOMY BARRIER AND HER SKIN STARTED ITCHING UNDER THE BARRIER; SHE WOULD SCRATCH IT AND IT WOULD START BLEEDING. THE DOCTOR PRESCRIBED NYSTATIN. THAT DID NOT HELP. SHE WILL BE TRIALING A DIFFERENT FORMULATION OF HOLLISTER'S OSTOMY BARRIERS TO SEE IF THAT MAKES A DIFFERENCE.