MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER; 1-PIECE DRAINABLE OSTOMY POUCH, SOFT CONVEX, FLEXTEND

Catalog Number	8578
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The barrier was not returned; 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 di information is available as the lot number was not provided.
Event or Problem Description
It was reported that an end user noticed skin irritation under the tape border of the hollister premier soft convex barrier.It was reported that the skin was bubbly.It was further reported that the end user went to the doctor who prescribed a powder.A different barrier was then recommended without a tape border.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE DRAINABLE OSTOMY POUCH, SOFT CONVEX, FLEXTEND
• 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: 20610410
• Report Number: 1119193-2024-00020
• Device Sequence Number: 8143829
• Product Code: EXB
• UDI-Device Identifier: 00610075185146
• UDI-Public: (01)00610075185146
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/05/2024

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 Catalogue Number: 8578
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/05/2024
• 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: 81 YR
• Patient Sex: Female