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

Model Number	8331
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Erosion (2075); Blister (4537)
Date of Event	03/14/2023
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 ulcers and blisters under the ostomy appliance cannot be independently confirmed.
Event or Problem Description
It was reported that the end user's supplier could not supply her usual hollister convex ostomy barrier pouching system so they provided her with a flat hollister ostomy pouching system.The end user reported that this had been going on for about 2 months.End user reported that since her stoma was flush to the skin, this allowed effluent leakage under the barrier which led to the need for frequent ostomy appliance changes.End user further reported that the frequent changes lead to 4 skin ulcers/blisters under the barrier.End user reported that one blister broke open and blood and pus came out.She reported that she went to the ed who provided her a paste and oral antibiotics.Hollister will provide samples of her convex pouching system to tide her over until she can get that product from her supplier.

• 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 VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 16558428
• Report Number: 1119193-2023-00004
• Device Sequence Number: 12185299
• Product Code: EXB
• UDI-Device Identifier: 00610075168576
• UDI-Public: 00610075168576
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/16/2023

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 Model Number: 8331
• 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: 03/15/2023
• Initial Report FDA Received Date: 03/16/2023
• 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: 67 YR
• Patient Sex: Female