MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY BARRIER

Model Number 14604

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 09/04/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Lot number not provided so device history records could not be reviewed.Sample not returned so sample evaluation not possible.Root cause of reported generalized reaction to the barrier of the ostomy appliance cannot be determined.

Event Description

It was reported that an end user, who had ileostomy surgery was put in the hollister 14604 ostomy barrier in the hospital.The end user reported that she started to have a skin reaction, so they gave her iv benadryl.She said she asked if they could switch her to a different barrier and they said no because that was the only barrier they had; and was consequently sent home in that barrier.She reported she had more of a reaction to the barrier at home including very red skin under the footprint of the barrier and generalized hives.She said she noticed her tongue was swelling so she went to the er where she reported they gave her two doses of her epipen for the reaction to subside.She said they then switched her to a different brand of ostomy barrier, and she is no longer having a reaction to the barrier.

• Brand Name: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY BARRIER
• Type of Device: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 15879799
• MDR Text Key: 304461959
• Report Number: 1119193-2022-00038
• Device Sequence Number: 1
• Product Code: EXB
• 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: 11/29/2022

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: 14604
• Device Catalogue Number: 14604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 11/29/2022
• 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: 53 YR
• Patient Sex: Female