PREMIER SOFT CONVEX DRAINABLE LOCK N ROLL POUCHING SYSTEM
Received Jan 18, 2022 · Event occurred Dec 31, 2021
Report 1119193-2022-00001 · MDR key 13284988
Device
Generic name
Premier Soft Convex Drainable Lock N Roll Pouching System
Manufacturer
Hollister IncroporatedCatalog number
85711
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
86 YR · Female
- Itching Sensation
- Skin Inflammation/ Irritation
- Itching Sensation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED FOR TAPE CAUSING SKIN IRRITATION . 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 SKIN IRRITATION UNDER THE TAPE BORDER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT ABOUT 3 WEEKS AGO AN END USER STARTED NOTICING SKIN IRRITATION, ITCHY AND PAINFUL SKIN UNDER THE TAPE BORDER OF THE HOLLISTER OSTOMY APPLIANCE. SHE ATTEMPTED TO TREAT IT AT HOME WITH BACITRACIN OINTMENT BUT IT DID NOT HELP. SHE CALLED HER DOCTOR WHO PRESCRIBED CEFOXITIN ORAL ANTIBIOTICS AS A PREVENTIVE AGAINST A BACTERIAL SKIN INFECTION. THE DOCTOR DID NOT SEE HER OR THE IRRITATED AREA ON HER SKIN BEFORE PRESCRIBING. END USER CALLED HOLLISTER AT WHICH TIME THE CRUSTING TECHNIQUE WAS EXPLAINED TO HER. SHE IS NOW USING THE STOMA POWDER UNDER THE TAPE BORDER FOR THE IRRITATED AREA AND THE AREA IS CLEARING UP.