NEW IMAGE CERAPLUS CUT TO FIT TAPE BORDERED BARRIER
Received Jun 15, 2021 · Event occurred Jun 11, 2020
Report 1119193-2021-00016 · MDR key 12000653
Device
Generic name
New Image Ceraplus Cut To Fit Tape Bordered Barrier
Manufacturer
Hollister IncorporatedCatalog number
11204
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
62 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 CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER HAS BEEN EXPERIENCING SKIN IRRITATION ON AND OFF OVER THE LAST YEAR UNDER THE HOLLISTER NEW IMAGE CERAPLUS BARRIER AND TAPE BORDER. SHE HAS AN AUTOIMMUNE DISEASE THAT CAUSES EXCESSIVE SWEATING AND ODOR. THE DOCTOR SAID THE IRRITATION IS BECAUSE OF THE AUTOIMMUNE DISEASE AND SWEATING. LAST YEAR THE DOCTOR PRESCRIBED NYSTATIN POWDER AND SILVADENE CREAM FOR HER TO USE AS NEEDED FOR THE IRRITATION. SHE STATES THAT THE MEDICINE IS WORKING BUT THE IRRITATION RETURNS DUE TO THE AUTOIMMUNE DISEASE.