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

Model Number	8538
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Tissue Irritation (4912)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review could not be conducted since lot number was not provided.Sample not returned so sample evaluation not possible.Root cause of the reported stoma laceration is related to the end user using the wrong sized product.This has since been addressed by the clinician.Only the di portion of the udi information is known due to lack of lot number.
Event or Problem Description
It was reported that an end user was using a pre cut 32mm hollister ostomy pouching system and was stretching it with his fingers to make it large enough to fit over the stoma even though it was too small.It was reported that the end user cut his stoma by doing this and ended up in the er.It was further reported that first the ostomy clinic tried using silver nitrate on the wound, which caused the end user to pass out.It was reported that the end user was then admitted to the er where they stitched the wound closed.A pouching system with a larger pre cut opening size has since been ordered.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE DRAINABLE OSTOMY POUCH, FLEXTEND
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24606928
• Report Number: 1119193-2026-00016
• Device Sequence Number: 10372559
• Product Code: EXB
• UDI-Device Identifier: 00610075085385
• UDI-Public: (01)00610075085385
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 8538
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/16/2026
• 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: 70 YR
• Patient Sex: Male