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

Catalog Number 11204

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

Patient Problem Rash (2033)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

The lot number is not known so the device history record review is not possible.The device not saved for return so device evaluation not possible.The trend analysis conducted showed no adverse trends.Estimates used for patient's weight because actual weight not provided.The root cause of the reported skin irritation cannot be determined.

Event Description

It was reported that an end user has been experiencing skin irritation on and off over the last year under the hollister new image ceraplus barrier and tape border.She has an autoimmune disease that causes excessive sweating and odor.The doctor said the irritation is because of the autoimmune disease and sweating.Last year the doctor prescribed nystatin powder and silvadene cream for her to use as needed for the irritation.She states that the medicine is working but the irritation returns due to the autoimmune disease.

• Brand Name: NEW IMAGE CERAPLUS CUT TO FIT TAPE BORDERED BARRIER
• Type of Device: NEW IMAGE CERAPLUS CUT TO FIT TAPE BORDERED BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 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: 12000653
• MDR Text Key: 256246937
• Report Number: 1119193-2021-00016
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2021
• 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: 62 YR
• Patient Weight: 68