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

Model Number	82711
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Skin Erosion (2075); Skin Infection (4544)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number is not known so only the di information from the udi is known.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 since the lot number was not provided.Based on the information provided, a root cause could not be determined.Hollister will continue to monitor this reported issue.
Event or Problem Description
It was reported that the end user had leakage and experienced skin break down with using the hollister premier one-piece drainable ostomy pouch - soft convex flextend barrier.It was reported that the end user has a crease/fold in his skin underneath the stoma which doesn't allow for a good seal and allows the accumulation of effluent in this crease.It was reported that the end user had been suffering with crohn's since 1968. it was further reported that the end user saw his wound care doctor who determined by culture that he had eight different bacteria's growing.It was reported that he was prescribed two antibiotics (oral medication and levoquin and flagil which is compounded into a spray).It was further reported that he was provided with different samples from hollister that he is trying now.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE DRAINABLE OSTOMY POUCH, CONVEX, FLEXTEND
• Manufacturer (Section D): HOLLISTER INCOPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: katelynn nitschneider ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8479321835
• MDR Report Key: 22965346
• Report Number: 1119193-2025-00031
• Device Sequence Number: 9109918
• Product Code: EXB
• UDI-Device Identifier: 00610075055319
• UDI-Public: (01)00610075055319
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 82711
• Device Catalogue Number: 82711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/04/2025
• 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: 85 YR
• Patient Sex: Male