CeraPlus 8815Recalls & reported problems
Hollister Incorporated · Ostomy Barrier Ring · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075097180), received between Apr 20, 2026 and Apr 20, 2026 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Erythema1
- Rash1
- Skin Inflammation/ Irritation1
- Urticaria1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN OSTOMATE EXPERIENCED SKIN IRRITATION, REDNESS AND OOZING UNDER THE BARRIER AFTER USING THREE DIFFERENT HOLLISTER PRODUCTS FOR A PERIOD OF TIME. THIS IS THE SECOND OF THE 3 PRODUCTS, 8815 HOLLISTER BARRIER RING. IT WAS REPORTED THAT THE PATIENT TRIED USING OTHER OSTOMY PRODUCTS AND THE IRRITATION BECAME WORSE. THE PATIENT REPORTED EVENTUALLY EXPERIENCING EXTREME ITCHINESS ON HIS ARMS, LEGS, CHEST AND BACK, WITH LITTLE BUMPS. THE PATIENT ALSO REPORTED HE WENT TO THE WOUND CARE NURSE AND WAS PRESCRIBED TRIAMCINOLONE CREAM AND A DIFFERENT BARRIER PRODUCT. IT WAS FURTHER REPORTED THAT THE REACTION CONTINUED AND THEN HE DEVELOPED A GENERALIZED REACTION WITH HIVES AND ITCHING OVER MOST OF HIS BODY. THE PATIENT REPORTED HE WENT TO THE URGENT CARE CENTER AND RECEIVED A STEROID SHOT AND A STEROID DOSE PACK AFTER WHICH HE FELT BETTER. HOLLISTER HAS ADVISED THE PATIENT TO SEEK ATTENTION FROM HIS HEALTH CARE PROFESSIONALS BEFORE USING THE HOLLISTER BARRIER AGAIN.
Patient problems: Erythema; Rash; Skin Inflammation/ Irritation; Urticaria
MAUDE report 24924970 ↗
Other Protector, ostomy devices
- NATURA 404593Convatec, Purchasing Department · PROTECTOR, OSTOMY2,403 reports
- SUR-FIT NATURA 413182Convatec, Purchasing Department · PROTECTOR, OSTOMY1,202 reports
- SUR-FIT NATURA 413180Convatec, Purchasing Department · PROTECTOR, OSTOMY1,190 reports
- SUR-FIT NATURA 413179Convatec, Purchasing Department · PROTECTOR, OSTOMY1,178 reports
- SUR-FIT NATURA 413181Convatec, Purchasing Department · PROTECTOR, OSTOMY974 reports
- NATURA 411802Convatec, Purchasing Department · PROTECTOR, OSTOMY966 reports
- NATURA 404592Convatec, Purchasing Department · PROTECTOR, OSTOMY907 reports
- SUR-FIT NATURA 413183Convatec, Purchasing Department · PROTECTOR, OSTOMY773 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.