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

Catalog Number	8961
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user had a skin reaction to the hollister ceraplus ostomy barrier.It was reported that the end user tried to wear each barrier for 7 days like she did with a previous type of barrier but when she changed her ceraplus barrier, the skin had red raised spots.She reported that her healthcare professional did a biopsy that came back as inflamed keratosis-like growths, and no cancer was detected.She then reported that the wocn felt she was reacting to the ceraplus ingredients, switched her to a non ceraplus hollister barrier, and had her use clobetasol topically, and her skin has now healed.
Additional Manufacturer Narrative
The barrier was not returned; 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.Regarding udi information, only di information is available as the lot number was not provided.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE DRAINABLE OSTOMY POUCH, SOFT CONVEX, CERAPLUS
• 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: 20586004
• Report Number: 1119193-2024-00019
• Device Sequence Number: 6528525
• Product Code: EXB
• UDI-Device Identifier: 00610075057092
• UDI-Public: (01)00610075057092
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/01/2024

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 Catalogue Number: 8961
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/01/2024
• 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: 74 YR
• Patient Sex: Female