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

Model Number 11906

Device Problem Unintended Movement (3026)

Patient Problems Abrasion (1689); Skin Infection (4544)

Event Date 02/02/2024

Event Type  Injury  

Event Description

It was reported that the new image ostomy barrier did not adhere well to the skin.It was reported that the lack of adhesion allowed the skin barrier to bunch up under the abdominal hernia binder and abraded the stoma resulting in some bleeding and a local infection with puss.It was further reported that the end user was taken to the er and treated with antibiotics to prevent it from getting worse.

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
• Type of Device: 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: 18776818
• MDR Text Key: 336192941
• Report Number: 1119193-2024-00005
• Device Sequence Number: 1
• Product Code: EXB
• 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: 02/26/2024

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: 11906
• Device Catalogue Number: 11906
• Device Lot Number: 3K072
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female