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

Catalog Number	14603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional 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.End user has a history of reactions to other medical products and contrast media.Root cause of reported reaction to the ostomy appliance cannot be determined.
Event or Problem Description
It was reported that an end user developed a skin reaction to the hollister new image ostomy barrier shortly after she started using it after stoma surgery.She reported she was hospitalized for the reaction and given steroids.She stated that once she was discharged and stopped the steroids, she started to develop the skin reaction again while she continued to use the hollister new image ostomy barrier.She reported that she saw a dermatologist who placed her on dupixent injections, which did not help her skin reaction.She also reported that she has tried other ostomy appliance manufacturer's products which also caused skin reactions.

• Brand Name: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
• Common Device Name: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT 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: 14428721
• Report Number: 1119193-2022-00015
• Device Sequence Number: 6635329
• Product Code: EXB
• UDI-Device Identifier: 00610075146031
• UDI-Public: 00610075146031
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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
• 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: 05/02/2022
• Initial Report FDA Received Date: 05/18/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 66 KG