NEW IMAGE CERAPLUS CUT TO FIT TAPE BORDERED BARRIER
Received Sep 14, 2021 · Event occurred Sep 6, 2021
Report 1119193-2021-00029 · MDR key 12468273
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
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 CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER STARTED EXPERIENCING SKIN IRRITATION UNDER HIS OSTOMY BARRIER 2 WEEKS AFTER BEING DISCHARGED HOME AFTER HIS SECOND OSTOMY SURGERY. THE IRRITATION INITIALLY BEGAN WHERE THERE WAS LEAKAGE UNDER THE BARRIER AND THEN IT LEAD TO RAW, ITCHY, RED SKIN ALL UNDER THE BARRIER. HE SAW A NURSE ON SEPTEMBER 6TH WHO PRESCRIBED NYSTATIN POWDER FOR THE AREA AND SAID HE SHOULD CONTACT HOLLISTER TO SAMPLE OTHER PRODUCTS. HOLLISTER IS SENDING HIM OTHER PRODUCTS TO TRY INCLUDING A CONVEX BARRIER. THE IRRITATED SKIN HAS SHOWN IMPROVEMENT SINCE STARTING THE NYSTATIN POWDER.