MAUDE Adverse Event Report: HOLLISTER INCORPORATED CERAPLUS; OSTOMY BARRIER RING

Model Number	8815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Urticaria (2278); Skin Inflammation/ Irritation (4545)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Device history record review was not conducted as the lot number was not provided.In vivo skin sensitization testing is performed to identify the potential risk of an allergic response.Some individuals may still be sensitive to a specific material that has met all sensitization test requirements, and the severity of the reaction cannot be predicted.Only the di of the udi information was provided because the lot number was not known.
Event or Problem Description
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.

• Brand Name: CERAPLUS
• Common Device Name: OSTOMY BARRIER RING
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: rebeca thomas ; 2000 hollister drive; libertyville, IL 60048-3781 ; 2246022874
• MDR Report Key: 24924970
• Report Number: 1119193-2026-00037
• Device Sequence Number: 21401616
• Product Code: EXE
• UDI-Device Identifier: 00610075097180
• UDI-Public: (01)00610075097180
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 8815
• Device Catalogue Number: 8815
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male