MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER; 1-PIECE UROSTOMY POUCH, FLEXTEND

Model Number	8442
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	11/20/2020
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 was completed based on the product and lot number and no issues were identified.Based on the information provided, a root cause for the skin stripping and rash could not be determined.Hollister will continue to monitor this reported issue.
Event or Problem Description
It was reported that an end user noticed that when he removed the hollister ostomy barrier from his skin, it pulled the skin away.The end user also reported that he was experiencing some leakage under the barrier which caused the skin to become raw and rashy.He further reported that this started several months after his stoma surgery in 2020 and he saw a wocn and a dermatologist for it at that time.He reported that he was prescribed betamethasone, and he has been using betamethasone on his skin as needed ever since.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE UROSTOMY POUCH, 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: 19502893
• Report Number: 1119193-2024-00011
• Device Sequence Number: 7870412
• Product Code: EXB
• UDI-Device Identifier: 00610075000999
• UDI-Public: 00610075000999
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/10/2024

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: 8442
• Device Catalogue Number: 8442
• Device Lot Number: 3E052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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: 65 YR
• Patient Sex: Male