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

Model Number	8958
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review could not be conducted due to lack of lot number information.Sample not returned so sample evaluation not possible.Root cause of reported irritation and wounds under the ostomy barrier cannot be determined.Only the di of the udi information is known due to lack of lot number information.
Event or Problem Description
It was reported that an end usedr was placed in hollister premier ostomy pouching system 8958 after surgery and went to a rehab to recover.It was reported that while in rehab, when her ostomy pouch was full, the staff, being understaffed, did not tend to her ostomy needs promptly.She reported that it led to effluent leakage under the barrier which led to skin irritation and peristomal skin wounds.It was further reported that she was hospitalized to receive wound care for these wounds and is scheduled for a stomal reversal next week.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE DRAINABLE OSTOMY POUCH, SOFT CONVEX, CERAPLUS
• 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: 25117564
• Report Number: 1119193-2026-00040
• Device Sequence Number: 18704419
• Product Code: EXB
• UDI-Device Identifier: 00610075057078
• UDI-Public: (01)00610075057078
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/07/2026

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: 8958
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/07/2026
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female