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

Catalog Number 8331

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Infection (4544)

Event Date 09/19/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 324167526
• Report Number: 1119193-2023-00007
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 00610075168576
• UDI-Public: 00610075168576
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8331
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male