MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE; 2-PIECE OSTOMY SKIN BARRIER, CERAPLUS

Model Number	11203
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Caustic/Chemical Burns (2549); Skin Inflammation/ Irritation (4545)
Date of Event	06/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The barrier was not saved; therefore, a device evaluation could not take place.A complaint history trend analysis was conducted for similar complaints and no adverse trends observed.A device history records (dhr) review could not be conducted because a lot number was not provided.Based on the information provided, a root cause of the event could not be determined.Hollister will continue to monitor this reported issue.
Event or Problem Description
It was reported that the end user has been receiving chemo for the last 4 years.It was reported that during this whole time, urine has been leaking under the urostomy barrier and burning his skin from the chemotherapy in the urine.It was reported that the skin looks like a 3rd degree burn, irritated, and was not getting any better.It was further reported that the doctor prescribed oral prednisone 3 days ago for a 5-day tapering schedule.It was reported that the skin is already feeling better.Hollister is sending out samples of other products to try.

• Brand Name: NEW IMAGE
• Common Device Name: 2-PIECE OSTOMY SKIN BARRIER, CERAPLUS
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 19665720
• Report Number: 1119193-2024-00012
• Device Sequence Number: 12399423
• Product Code: EXB
• UDI-Device Identifier: 00610075029846
• UDI-Public: 00610075029846
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 11203
• Device Catalogue Number: 11203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/03/2024
• 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: 78 YR
• Patient Sex: Male