New Image 11504Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610075029907), received between Nov 22, 2022 and Feb 14, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED THAT SHE EXPERIENCED IRRITATION UNDER THE BARRIER, THE TAPE BORDER AND BEYOND THE EDGES OF THE HOLLISTER NEW IMAGE BARRIER A LITTLE OVER TWO WEEKS AGO. SHE REPORTED SHE SAW HER DERMATOLOGIST WHO SAID IT WAS CONTACT DERMATITIS AND PRESCRIBED A CREAM. SHE DESCRIBES HER SKIN AS BEING OOZY, RED, BLEEDING, ITCHING, BURNING AND STICKY. SHE SAID SHE USED THE PRESCRIBED CLOBETASOL PROPIONATE CREAM FOR JUST UNDER TWO WEEKS AND SINCE HER SKIN WAS GETTING BETTER, SHE STOPPED USING IT. SHE SAID THE SKIN IRRITATION CAME BACK WHEN SHE STOPPED USING IT. SHE REPORTED HER DOCTOR INSTRUCTED HER TO USE THE CREAM AGAIN BUT THIS TIME FOR THE FULL TWO WEEKS.

  Patient problems: Erythema; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 16371779 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OSTOMATE HAS BEEN EXPERIENCING SKIN IRRITATION UNDER THE TAPE BORDER OF HIS NEW IMAGE BARRIER ON AND OFF SINCE HE STARTED USING IT IN 2019. HE REPORTED THAT WHEN HE HAS THE SKIN IRRITATION, HE ALSO EXPERIENCES WATERY EYES. HE STATED HE HAS BEEN TO AN ALLERGIST WHO CONDUCTED PATCH TESTING WHICH WAS NEGATIVE, AND IT COULD NOT BE DETERMINED WHY HE EXPERIENCES THIS RESPONSE. HE REPORTED THAT HE TAKES OVER THE COUNTER ANTIHISTAMINES AND USES A PRESCRIPTIVE STEROID CREAM CALLED FLUOCINONIDE FOR THE OCCASIONAL SKIN IRRITATION. HE STATED HE USES THE CREAM SPARINGLY AND HAS BEEN USING IT ON AND OFF SINCE 2019. HE RECENTLY LEARNED THAT HOLLISTER CARRIES BARRIERS WITHOUT A TAPE BORDER, SO HE CALLED TO REQUEST SAMPLES.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 15844791 ↗