MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER FLAT OSTOMY LNR POUCH WITH CUT TO FIT BARRIER

Catalog Number	8331
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number not provided so dhr review not possible.Sample not returned so sample review not possible.Root cause of reported fungal infection under the ostomy appliance cannot be determined.Causal relationship cannot be established.
Event or Problem Description
It was reported that a patient who was placed in the hollister premier ostomy barrier experienced a fungal skin infection under the barrier.It was reported that the er told him to change the barrier 4x a day and use ketoconazole 2% and triamcinolone.

• Brand Name: PREMIER FLAT OSTOMY LNR POUCH WITH CUT TO FIT BARRIER
• Common Device Name: PREMIER FLAT OSTOMY LNR POUCH WITH CUT TO FIT BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL
• MDR Report Key: 17809611
• Report Number: 1119193-2023-00007
• Device Sequence Number: 12501065
• Product Code: EXB
• UDI-Device Identifier: 00610075168576
• UDI-Public: 00610075168576
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2023

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 Catalogue Number: 8331
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 79 YR
• Patient Sex: Male