MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE; 2-PIECE OSTOMY SKIN BARRIER, SOFT CONVEX, CERAPLUS

Model Number	11702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user experienced skin irritation under the tape border of the hollister 11702 new image ostomy barrier.She reported that the skin was red and had sores that were oozing and went to the ed.The ed prescribed prednisone and collected a urine sample.It was further reported that two days later, the end user was informed that the urine culture came back positive for staphylococcus and was prescribed antibiotics.In addition, it was reported the end user was told it is not known if the skin irritation under the tape border was an allergic reaction to the hollister product or was due to the staph infection from her urine.The end user reports that now, two days later, the sores are healing.
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 was completed based on the product and lot number and no issues were identified.Based on the information provided, a root cause could not be determined.Hollister will continue to monitor this reported issue.

• Brand Name: NEW IMAGE
• Common Device Name: 2-PIECE OSTOMY SKIN BARRIER, 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: 19485083
• Report Number: 1119193-2024-00010
• Device Sequence Number: 15430180
• Product Code: EXB
• UDI-Device Identifier: 00610075069071
• UDI-Public: 00610075069071
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/07/2024

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: 11702
• Device Catalogue Number: 11702
• Device Lot Number: 4C152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female