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

Model Number 11504

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 11/01/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 304120085
• Report Number: 1119193-2022-00037
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 11504
• Device Catalogue Number: 11504
• Device Lot Number: 2G192
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male