New Image 11702Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075069071), received between Jun 7, 2024 and Jun 7, 2024 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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.

  Patient problems: Erythema; Rash; Skin Inflammation/ Irritation

  MAUDE report 19485083 ↗