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

Model Number	8512
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pouch 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 conducted, and the records were found to be complete and accurate.Based on the information provided, a root cause of lock 'n roll closure opening on its own could not be determined.No causation could be established between the fecal effluent leakage and the reported uti.Hollister will continue to monitor this reported issue.
Event or Problem Description
It was reported that the lock 'n roll closer at the bottom of the hollister ostomy pouch opened in use and the ileostomy fecal material leaked out.It was further reported that the leakage got on the end user's lower abdomen and upper leg area.It was reported that the end user then developed a uti and the end user concluded that it must have been from the fecal matter that leaked, contaminating his penis area.It was reported that the end user went to the er where the uti diagnosis was made, they did not indicate what caused or contributed to the uti, and they prescribed a 10-day course of antibiotics to treat the uti.Additionally, it was reported that now, 4 days later, he is feeling better and hollister is providing him samples of an ostomy pouch with a different type of closure to try.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE DRAINABLE OSTOMY POUCH, 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: 20335559
• Report Number: 1119193-2024-00017
• Device Sequence Number: 20833981
• Product Code: EXB
• UDI-Device Identifier: 00610075085125
• UDI-Public: (01)00610075085125(17)270101(30)5(10)2A242
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/30/2024

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: 8512
• Device Catalogue Number: 8512
• Device Lot Number: 2A242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2022
• 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: 78 YR
• Patient Sex: Male