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

Model Number 14904

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/12/2024

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 the tape border on the new image ostomy barrier irritated the end user's skin.It was reported that the end user has history of sensitivity to adhesives but never had any issue in the past with this sku.It was reported that a few months ago, the end user's skin became irritated and itchy and that she needed to change the barrier every day.It was further reported that she saw her doctor who said she should use the over-the-counter antifungal cream, lotrimin, and to use the prescriptive steroid cream, triamcinolone 0.1% for the irritated area.It was reported that the end user switched barrier products and along with the creams, the irritated skin under the tape border has now cleared up.

• Brand Name: NEW IMAGE
• Type of Device: 2-PIECE OSTOMY SKIN BARRIER, CONVEX, 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: 18907812
• MDR Text Key: 337705371
• Report Number: 1119193-2024-00007
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 00610075149049
• UDI-Public: 00610075149049
• 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: 03/14/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 14904
• Device Catalogue Number: 14904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA 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: 77 YR
• Patient Sex: Female