New Image 14603Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610075146031), received between May 18, 2022 and Dec 12, 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.

• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER STARTED EXPERIENCING IRRITATION UNDER THE HOLLISTER NEW IMAGE OSTOMY BARRIER ABOUT 3 TO 4 MONTHS AGO. IT WAS FURTHER REPORTED THE END USER CONTINUED TO USE EACH BARRIER LONGER THAN THEY SHOULD, EVEN PAST THE POINT OF SKIN IRRITATION, DUE TO LACK OF SUPPLIES. THE END USER REPORTED THE IRRITATION PROGRESSED INTO TWO SORES UNDER THE OSTOMY BARRIER BY THE STOMA AND SAW THE HEALTH CARE PROFESSIONAL ABOUT IT ON NOVEMBER 17TH. IT WAS REPORTED THAT THE DOCTOR PRESCRIBED CIPRO BY MOUTH FOR 10 DAYS, AND THE END USER REPORTED THAT ONE OF THE TWO SORES CLEARED UP. IT WAS FURTHER REPORTED THAT AFTER THE COURSE OF ANTIBIOTICS, THE END USER CALLED HOLLISTER FOR ADVICE. IT WAS REPORTED THAT HOLLISTER MADE SOME RECOMMENDATIONS, AND THE END USER REPORTED THE SECOND SORE CLEARED UP. THE END USER REPORTED THERE HAS NOT BEEN ANY SORES SINCE. THE END USER NOW REPORTS HAVING A THREE-MONTH SUPPLY OF OSTOMY APPLIANCES.

  Patient problems: Skin Erosion

  MAUDE report 18311321 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER DEVELOPED A SKIN REACTION TO THE HOLLISTER NEW IMAGE OSTOMY BARRIER SHORTLY AFTER SHE STARTED USING IT AFTER STOMA SURGERY. SHE REPORTED SHE WAS HOSPITALIZED FOR THE REACTION AND GIVEN STEROIDS. SHE STATED THAT ONCE SHE WAS DISCHARGED AND STOPPED THE STEROIDS, SHE STARTED TO DEVELOP THE SKIN REACTION AGAIN WHILE SHE CONTINUED TO USE THE HOLLISTER NEW IMAGE OSTOMY BARRIER. SHE REPORTED THAT SHE SAW A DERMATOLOGIST WHO PLACED HER ON DUPIXENT INJECTIONS, WHICH DID NOT HELP HER SKIN REACTION. SHE ALSO REPORTED THAT SHE HAS TRIED OTHER OSTOMY APPLIANCE MANUFACTURER'S PRODUCTS WHICH ALSO CAUSED SKIN REACTIONS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14428721 ↗