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

Catalog Number	14803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/18/2020
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.Root cause of reported irritation under the ostomy barrier and tape border cannot be determined.
Event or Problem Description
It was reported that an end user developed skin irritation under the hollister new image ostomy barrier approximately 1 ½ years ago.She was told it was a yeast infection which became septic and she was hospitalized.She reported that the skin irritation has never gone away fully.She reports now having blisters on the skin and it is very itchy.She states this is under both the barrier and the tape border of the barrier.She reports she was prescribed miconazole which did not work fully so she was recently prescribed betamethasone and clotrimazole ointment.She reports that is helping.She reports having an allergy to adhesives.Hollister customer service is sending her samples of ceraplus barriers for her to try.

• 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: 14490290
• Report Number: 1119193-2022-00019
• Device Sequence Number: 17485985
• Product Code: EXB
• UDI-Device Identifier: 20610075148039
• UDI-Public: 00610075148035
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/24/2022

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: 14803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/24/2022
• 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: 69 YR
• Patient Sex: Female