MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER; 1-PIECE UROSTOMY POUCH, SOFT CONVEX, CERAPLUS

Model Number	8414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A lot number was not provided so the device history records were not able to be reviewed.No samples were available for return so device examination not possible.Complaint data review was conducted, and no adverse trends observed.The root cause of the reported skin irritation could not be determined.Causation has not been established.Since a lot number was not provided, only gudid di information is available.
Event or Problem Description
It was reported that an end user has been experiencing irritated skin under the hollister ostomy barrier since march of this year.It was reported that the peristomal skin is itchy, red and bumpy.It was further reported that the irritated skin continued despite using different types of ostomy barriers over a period of time.It was further reported that he was prescribed clobetasol propionate cream to be used on his irritated skin under the appliance for two weeks.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE UROSTOMY POUCH, SOFT CONVEX, CERAPLUS
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 20213288
• Report Number: 9616668-2024-00005
• Device Sequence Number: 7774348
• Product Code: EXG
• UDI-Device Identifier: 00610075064496
• UDI-Public: 00610075064496
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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: 8414
• Device Catalogue Number: 8414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/13/2024
• 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: 77 YR
• Patient Sex: Male