MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXTEND CTF BARRIER

Catalog Number 14603

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

Patient Problem Skin Erosion (2075)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Lot number not provided so dhr review not possible.Sample not returned so sample review not possible.Root cause of reported sores under the ostomy barrier cannot be determined.Causal relationship cannot be established.

Event Description

It was reported that an end user started experiencing irritation under the hollister new image ostomy barrier about 3 to 4 months ago.It was further reported the end user continued to use each barrier longer than they should, even past the point of skin irritation, due to lack of supplies.The end user reported the irritation progressed into two sores under the ostomy barrier by the stoma and saw the health care professional about it on november 17th.It was reported that the doctor prescribed cipro by mouth for 10 days, and the end user reported that one of the two sores cleared up.It was further reported that after the course of antibiotics, the end user called hollister for advice.It was reported that hollister made some recommendations, and the end user reported the second sore cleared up.The end user reported there has not been any sores since.The end user now reports having a three-month supply of ostomy appliances.

• Brand Name: NEW IMAGE FLEXTEND CTF BARRIER
• Type of Device: NEW IMAGE FLEXTEND CTF BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 18311321
• MDR Text Key: 330287963
• Report Number: 1119193-2023-00010
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 00610075146031
• UDI-Public: 00610075146031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 12/12/2023

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 Catalogue Number: 14603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Sex: Female