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

Model Number 8331

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

Patient Problems Skin Erosion (2075); Blister (4537)

Event Date 03/14/2023

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 ulcers and blisters under the ostomy appliance cannot be independently confirmed.

Event 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
• 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 VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 16558428
• MDR Text Key: 311474181
• Report Number: 1119193-2023-00004
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 8331
• Device Catalogue Number: 8331
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/16/2023
• 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: 67 YR
• Patient Sex: Female