New Image 14803Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00610075148035), received between Apr 26, 2022 and Dec 13, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER DEVELOPED WHAT SHE REPORTED TO BE AN ALLERGIC REACTION TO THE HOLLISTER NEW IMAGE BARRIER. SHE SAID THAT HER SKIN ITCHES. SHE SAID SHE HAS USED THIS PRODUCT FOR 3 TO 4 YEARS AND HAS NOT BEEN ABLE TO RESOLVE THE ITCHINESS. SHE REPORTED THAT SHE SAW HER DOCTOR WHO PROVIDED HER WITH A PRESCRIPTION FOR TRIAMCINOLONE ACETONIDE CREAM. HOLLISTER IS SENDING HER SAMPLES OF A DIFFERENT FORMULATION OF NEW IMAGE BARRIER FOR HER TO TRY.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 15968494 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER DEVELOPED SKIN IRRITATION UNDER THE HOLLISTER NEW IMAGE OSTOMY BARRIER APPROXIMATELY 1 ½ YEARS AGO. SHE WAS TOLD IT WAS A YEAST INFECTION WHICH BECAME SEPTIC AND SHE WAS HOSPITALIZED. SHE REPORTED THAT THE SKIN IRRITATION HAS NEVER GONE AWAY FULLY. SHE REPORTS NOW HAVING BLISTERS ON THE SKIN AND IT IS VERY ITCHY. SHE STATES THIS IS UNDER BOTH THE BARRIER AND THE TAPE BORDER OF THE BARRIER. SHE REPORTS SHE WAS PRESCRIBED MICONAZOLE WHICH DID NOT WORK FULLY SO SHE WAS RECENTLY PRESCRIBED BETAMETHASONE AND CLOTRIMAZOLE OINTMENT. SHE REPORTS THAT IS HELPING. SHE REPORTS HAVING AN ALLERGY TO ADHESIVES. HOLLISTER CUSTOMER SERVICE IS SENDING HER SAMPLES OF CERAPLUS BARRIERS FOR HER TO TRY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14490290 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER EXPERIENCED PAIN AND REDNESS ON HER SKIN AFTER REMOVING HER HOLLISTER OSTOMY EXTENDED WEAR BARRIER THAT HAD ONLY BEEN IN PLACE FOR SEVERAL HOURS. SHE REPORTED THAT THE BARRIER WAS DIFFICULT TO REMOVE. SHE REPORTED THAT SHE APPLIED A NEW BARRIER BUT NEEDED TO REMOVE IT LATER THAT DAY BECAUSE HER SKIN WAS BURNING AND ITCHING. SHE REPORTED THAT AGAIN WAS DIFFICULT TO REMOVE AND WHEN SHE REMOVED THE BARRIER, THERE WERE BLISTERS AND REDNESS ON HER SKIN THAT EXTENDED BEYOND THE EDGES OF THE BARRIER. SHE REPORTED SHE WENT TO HER DOCTOR THE NEXT DAY WHO SAID SHE MAY BE EXPERIENCING AN ALLERGIC REACTION, ALTHOUGH NO ALLERGY TESTING WAS DONE. SHE REPORTED HE PRESCRIBED CLOTRIMAZOLE BETAMETHASONE (ANTIFUNGAL & CORTICOSTEROID) CREAM TO TREAT THE AFFECTED AREA. SHE SAID SHE IS SEEING SLIGHT IMPROVEMENT ALREADY. HOLLISTER IS SENDING DIFFERENT BARRIER PRODUCTS FOR HER TO TRY.

  Patient problems: Skin Inflammation/ Irritation; Urticaria

  MAUDE report 14209774 ↗