NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
Received May 26, 2020 · Event occurred May 10, 2020
Report 1119193-2020-00010 · MDR key 10088086
Device
Generic name
New Image Flextend Tape Bordered Cut To Fit Barrier
Manufacturer
Hollister IncorporatedCatalog number
14603
Lot number
0B212
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
78 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
END USER'S WEIGHT NOT KNOWN SO ESTIMATION USED. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW CONDUCTED AND RESULTS FOUND TO BE COMPLETE AND ACCURATE. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. SINCE NYSTOP WAS PRESCRIBED FOR HER IRRITATED SKIN, THIS IS CONSIDERED AN MDR REPORTABLE EVENT. THE ROOT CAUSE OF THE EFFLUENT LEAKAGE CANNOT BE DETERMINED BUT THE PROCESS OF FINDING THE RIGHT BARRIER FIT MAY HAVE CONTRIBUTED TO THIS.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED LEAKAGE UNDER HER HOLLISTER OSTOMY BARRIER WHICH LEAD TO SKIN IRRITATION. SHE WAS PRESCRIBED NYSTOP POWDER FOR HER IRRITATED SKIN AND IT HAS HELPED. HOLLISTER IS SENDING A SAMPLE OF A DIFFERENT BARRIER PRODUCT FOR HER TO TRY TO SEE IF IT WORKS BETTER.