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

Catalog Number	14603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1119193-2023-00010
• Device Sequence Number: 6626339
• Product Code: EXB
• UDI-Device Identifier: 00610075146031
• UDI-Public: 00610075146031
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 14603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female