NEW IMAGE
Received Jun 7, 2024 · Event occurred Jun 3, 2024
Report 1119193-2024-00010 · MDR key 19485083
Device
Generic name
2-piece Ostomy Skin Barrier, Soft Convex, Ceraplus
Manufacturer
Hollister IncorporatedModel number
11702Catalog number
11702
Lot number
4C152
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR · Female
- Erythema
- Rash
- Skin Inflammation/ Irritation
- Erythema
- Rash
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED SKIN IRRITATION UNDER THE TAPE BORDER OF THE HOLLISTER 11702 NEW IMAGE OSTOMY BARRIER. SHE REPORTED THAT THE SKIN WAS RED AND HAD SORES THAT WERE OOZING AND WENT TO THE ED. THE ED PRESCRIBED PREDNISONE AND COLLECTED A URINE SAMPLE. IT WAS FURTHER REPORTED THAT TWO DAYS LATER, THE END USER WAS INFORMED THAT THE URINE CULTURE CAME BACK POSITIVE FOR STAPHYLOCOCCUS AND WAS PRESCRIBED ANTIBIOTICS. IN ADDITION, IT WAS REPORTED THE END USER WAS TOLD IT IS NOT KNOWN IF THE SKIN IRRITATION UNDER THE TAPE BORDER WAS AN ALLERGIC REACTION TO THE HOLLISTER PRODUCT OR WAS DUE TO THE STAPH INFECTION FROM HER URINE. THE END USER REPORTS THAT NOW, TWO DAYS LATER, THE SORES ARE HEALING.
Additional Manufacturer Narrative
THE BARRIER WAS NOT SAVED; THEREFORE, A DEVICE EVALUATION COULD NOT TAKE PLACE. A COMPLAINT HISTORY TREND ANALYSIS WAS CONDUCTED FOR SIMILAR COMPLAINTS AND NO ADVERSE TRENDS OBSERVED. A DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED BASED ON THE PRODUCT AND LOT NUMBER AND NO ISSUES WERE IDENTIFIED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.