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

Model Number	11703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	10/05/2024
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.Regarding udi information, only the di information is available.Since the lot number was not provided, the pi information is not available.
Event or Problem Description
It was reported that skin irritation developed under the barrier of the hollister new image soft convex ostomy barrier.It was reported that it had been going on for a month, not specific to any particular lot of product, and hadn't been clearing up.It was further reported that it was determined to be a yeast infection and nystatin powder was prescribed for use under the barrier.It went on to report that the nystatin powder treatment began yesterday, and he has not yet seen any improvement.

• Brand Name: NEW IMAGE
• Common Device Name: 2-PIECE OSTOMY SKIN BARRIER, SOFT CONVEX, 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: 20635810
• Report Number: 1119193-2024-00021
• Device Sequence Number: 20705107
• Product Code: EXB
• UDI-Device Identifier: 00610075069088
• UDI-Public: (01)00610075069088
• 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): 11/07/2024

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: 11703
• Device Catalogue Number: 11703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/07/2024
• 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: 73 YR
• Patient Sex: Male