NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
Received May 18, 2022 · Event occurred Mar 30, 2022
Report 1119193-2022-00015 · MDR key 14428721
Device
Generic name
New Image Flextend Tape Bordered Cut To Fit Barrier
Manufacturer
Hollister IncroporatedCatalog number
14603
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
46 YR · Female
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. LOT NUMBER NOT PROVIDED SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. END USER HAS A HISTORY OF REACTIONS TO OTHER MEDICAL PRODUCTS AND CONTRAST MEDIA. ROOT CAUSE OF REPORTED REACTION TO THE OSTOMY APPLIANCE CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED A SKIN REACTION TO THE HOLLISTER NEW IMAGE OSTOMY BARRIER SHORTLY AFTER SHE STARTED USING IT AFTER STOMA SURGERY. SHE REPORTED SHE WAS HOSPITALIZED FOR THE REACTION AND GIVEN STEROIDS. SHE STATED THAT ONCE SHE WAS DISCHARGED AND STOPPED THE STEROIDS, SHE STARTED TO DEVELOP THE SKIN REACTION AGAIN WHILE SHE CONTINUED TO USE THE HOLLISTER NEW IMAGE OSTOMY BARRIER. SHE REPORTED THAT SHE SAW A DERMATOLOGIST WHO PLACED HER ON DUPIXENT INJECTIONS, WHICH DID NOT HELP HER SKIN REACTION. SHE ALSO REPORTED THAT SHE HAS TRIED OTHER OSTOMY APPLIANCE MANUFACTURER'S PRODUCTS WHICH ALSO CAUSED SKIN REACTIONS.