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); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user reported that she experienced irritation under the barrier, the tape border and beyond the edges of the hollister new image barrier a little over two weeks ago.She reported she saw her dermatologist who said it was contact dermatitis and prescribed a cream.She describes her skin as being oozy, red, bleeding, itching, burning and sticky.She said she used the prescribed clobetasol propionate cream for just under two weeks and since her skin was getting better, she stopped using it.She said the skin irritation came back when she stopped using it.She reported her doctor instructed her to use the cream again but this time for the full two weeks.
Additional Manufacturer Narrative
Trend analysis conducted for device causing skin irritation for this sku and no adverse trends observed.Device history record (dhr) review conducted, 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 cannot be determined.

• 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: 16371779
• Report Number: 1119193-2023-00002
• Device Sequence Number: 6757643
• Product Code: EXB
• UDI-Device Identifier: 00610075029907
• UDI-Public: 00610075029907
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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: 2J232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 02/14/2023
• 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: Female