PREMIER CERAPLUS CUT TO FIT BARRIER WITH DRAINABLE POUCH
Received Sep 15, 2020 · Event occurred Aug 25, 2020
Report 1119193-2020-00024 · MDR key 10535544
Device
Generic name
Premier Ceraplus Cut To Fit Barrier With Drainable Pouch
Manufacturer
Hollister IncorporatedCatalog number
8901
Lot number
0F152
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR
- Skin Infection
- Skin Infection
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ISSUES IDENTIFIED. ROOT CAUSE OF THE REPORTED SKIN INFECTION CANNOT BE DETERMINED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED SKIN IRRITATION, REDNESS AND ITCHING UNDER THE TAPE PORTION OF THE HOLLISTER OSTOMY BARRIER. HE WENT TO THE ER ON (B)(6) 2020 FOR THIS AND WAS DIAGNOSED WITH IMPETIGO AND PRESCRIBED MUPIROCIN OINTMENT TO APPLY TO THE AFFECTED AREA. THE AREA CLEARED UP BUT IT STARTED UP AGAIN WHEN HE USED THE TAPE OVER THAT AREA AGAIN. HE REPORTS HAVING SENSITIVE SKIN. IRRITATION HAS OCCURRED BEFORE WHEN USING ANOTHER OSTOMY APPLIANCE BRAND. HOLLISTER WILL SEND HIM PRODUCT TO SAMPLE THAT DOES NOT HAVE A TAPE BORDER.