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

Model Number	14803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Date of Event	11/28/2022
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.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 what she reported to be an allergic reaction to the hollister new image barrier.She said that her skin itches.She said she has used this product for 3 to 4 years and has not been able to resolve the itchiness.She reported that she saw her doctor who provided her with a prescription for triamcinolone acetonide cream.Hollister is sending her samples of a different formulation of new image barrier 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: 15968494
• Report Number: 1119193-2022-00039
• Device Sequence Number: 17381253
• Product Code: EXB
• UDI-Device Identifier: 20610075148039
• UDI-Public: 00610075148035
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/13/2022

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 Model Number: 14803
• 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: 11/29/2022
• Initial Report FDA Received Date: 12/13/2022
• 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: 71 YR
• Patient Sex: Female