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

Model Number	88400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The barrier 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 could not be conducted because a lot number was not provided.Based on the information provided, a root cause of the event could not be determined.Hollister will continue to monitor this reported issue.
Event or Problem Description
It was reported that the end user had been experiencing irritation around the stoma under the hollister premier barrier for a while due to leakage of output and went to the er in may.It was reported that the er said to use the no sting gel and cream (provided by the er), then powder under the barrier.It was reported that the end user was prescribed clotrimazole betamethasone cream 15 gm and lidocaine hydrochloride gel 100 mg.It was reported that the end user has continued to use the prescribed topical medication whenever the skin is irritated from output resting on the skin.It was further reported that the end user called hollister because they were running out of ostomy supplies from frequent appliance changes and hollister is sending out samples of different products for them to try in order to see if it works better for them.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE DRAINABLE OSTOMY POUCH, SOFTFLEX
• 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: 19724028
• Report Number: 1119193-2024-00014
• Device Sequence Number: 18175253
• Product Code: EXB
• UDI-Device Identifier: 00610075106509
• UDI-Public: 00610075106509
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 07/11/2024

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: 88400
• Device Catalogue Number: 88400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 63 YR
• Patient Sex: Male