NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
Received Jul 28, 2020 · Event occurred Jul 17, 2018
Report 1119193-2020-00017 · MDR key 10333347
Device
Generic name
New Image Flextend Tape Bordered Cut To Fit Barrier
Manufacturer
Hollister IncorporatedCatalog number
14603
Lot number
9J122
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
43 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. THE ROOT CAUSE OF THE SKIN IRRITATION CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER HAS BEEN EXPERIENCING SKIN IRRITATION OF HIS PERISTOMAL SKIN OVER THE PAST 2 YEARS WHILE USING THE HOLLISTER OSTOMY BARRIER. HE HAS BEEN TO A DERMATOLOGIST WHO DIAGNOSED IT AS ATOPIC DERMATITIS AND WAS PRESCRIBED METHOTREXATE AND DOXYCYCLINE. THIS CONDITION RESOLVES AND THEN REAPPEARS. HE WILL FOLLOW UP WITH HIS OSTOMY NURSE AND HOLLISTER IS SENDING OTHER SAMPLES OF OSTOMY BARRIERS FOR HIM TO TRY.