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

Catalog Number 11204

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

Patient Problems Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 08/24/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends for skin irritation identified.Device history record (dhr) could not be reviewed because lot number not provided.Sample not returned so sample evaluation not possible.Root cause of reported skin irritation under the ostomy barrier and tape cannot be determined.

Event Description

It was reported that an end user experienced skin burning under the hollister new image barrier and tape border.She also reported that her skin bleeds when cleaning her skin.She reported that her doctor gave her a silver preparation for the burn.

• 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: 15454581
• MDR Text Key: 300221941
• Report Number: 1119193-2022-00029
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• 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: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic