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

Model Number 16104

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/14/2024

Event Type  Injury  

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 take place since no lot number was provided.There was no report of product malfunction.Based on the information provided, a root cause could not be determined.Hollister will continue to monitor this reported issue.

Event Description

It was reported that over a year ago an end user experienced skin irritation under the tape border of the hollister 16104 new image ostomy barrier.The end user report that at that time he was prescribed clobetasol cream by his health care professional.He further reported that the cream cleared up the irritation and now he is sampling barriers without the tape border.

• Brand Name: NEW IMAGE
• Type of Device: 2-PIECE OSTOMY SKIN BARRIER, FLEXTEND
• 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: 18935347
• MDR Text Key: 338042336
• Report Number: 1119193-2024-00008
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 00610075112937
• UDI-Public: 00610075112937
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 16104
• Device Catalogue Number: 16104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 66 YR
• Patient Sex: Male