MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CONVEX CERAPLUS TAPE BORDERED PRESIZED BARRIER

Model Number	11504
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Skin Inflammation/ Irritation (4545)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis conducted for tape border causing skin irritation for this sku and no adverse trends observed.Device history record (dhr) review conducted based upon the lot number provided and the records were found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of reported skin irritation under the ostomy appliance tape border cannot be determined.
Event or Problem Description
It was reported that an ostomate has been experiencing skin irritation under the tape border of his new image barrier on and off since he started using it in 2019.He reported that when he has the skin irritation, he also experiences watery eyes.He stated he has been to an allergist who conducted patch testing which was negative, and it could not be determined why he experiences this response.He reported that he takes over the counter antihistamines and uses a prescriptive steroid cream called fluocinonide for the occasional skin irritation.He stated he uses the cream sparingly and has been using it on and off since 2019.He recently learned that hollister carries barriers without a tape border, so he called to request samples.

• Brand Name: NEW IMAGE CONVEX CERAPLUS TAPE BORDERED PRESIZED BARRIER
• Common Device Name: NEW IMAGE CONVEX CERAPLUS TAPE BORDERED PRESIZED 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: 15844791
• Report Number: 1119193-2022-00037
• Device Sequence Number: 6901916
• Product Code: EXB
• UDI-Device Identifier: 00610075029907
• UDI-Public: 00610075029907
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/22/2022

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: 11504
• Device Catalogue Number: 11504
• Device Lot Number: 2G192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 11/22/2022
• 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: 66 YR
• Patient Sex: Male