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

Catalog Number 11203

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported that a new ostomate went to the ed one day after she started experiencing skin irritation that was hot, painful and prickly under the barrier and tape portion of a hollister new image barrier.She reported that the skin had blisters that broke open and were bleeding.She reported that the ed said it was an allergic reaction and a skin infection.She further reported that she was given prednisone in the ed and was sent home on prednisone, keflex, benadryl and pepcid.She reports that now, a week later, she is using a barrier product that is tapeless and the skin is improving.

Manufacturer Narrative

Trend analysis conducted and no other complaints for this sku and lot number found.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 barrier and tape cannot be determined.

• Brand Name: NEW IMAGE CERAPLUS TAPE BORDERED CUT TO FIT BARRIER
• Type of Device: NEW IMAGE CERAPLUS 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: 15013162
• MDR Text Key: 295863976
• Report Number: 1119193-2022-00024
• 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: 07/14/2022

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 Catalogue Number: 11203
• Device Lot Number: 2D142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/14/2022
• 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: 41 YR
• Patient Sex: Female