NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY BARRIER
Received Jun 21, 2022 · Event occurred May 15, 2022
Report 1119193-2022-00020 · MDR key 14755645
Device
Generic name
New Image Flextend Tape Bordered Cut To Fit Ostomy Barrier
Manufacturer
Hollister IncroporatedCatalog number
14604
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR · Female
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN END USER, WHO HAD BEEN USING HOLLISTER OSTOMY PRODUCTS FOR THE LAST 10 YEARS, STARTED EXPERIENCING SKIN IRRITATION UNDER THE OSTOMY BARRIER LAST MONTH. SHE REPORTED THAT HER SKIN WAS RED AND WARM TO TOUCH. SHE REPORTED THAT SHE WENT TO THE ED WHO TOLD HER IT WAS CONTACT DERMATITIS. SHE REPORTED THAT THE ED GAVE HER A PAIN SHOT, AND ANTIBIOTICS SHOT. SHE ALSO REPORTED SHE WAS SENT HOME WITH A PRESCRIPTION FOR ANTIBIOTICS AND ASCEND SILVER SULFADIAZINE 1% CREAM FOR HER IRRITATED SKIN. END USER REPORTED THAT HER SKIN HAS SINCE IMPROVED BUT NOT COMPLETELY. END USER WILL TRIAL OTHER HOLLISTER OSTOMY PRODUCTS TO SEE IF THAT WORKS BETTER FOR HER.
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. ROOT CAUSE OF REPORTED CONTACT DERMATITIS TO THE BARRIER OF THE OSTOMY APPLIANCE CANNOT BE DETERMINED.