MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND PRE SIZED BARRIER

Catalog Number 14703

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

Patient Problems Rash (2033); Blister (4537)

Event Date 01/22/2021

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 for skin irritation. The root cause of the skin irritation is not known. In addition, it is not known if the hollister barriers caused or contributed to this reported issue.

Event Description

It was reported that an end user who had been using hollister ostomy barriers for over a year, recently developed blisters of various sizes under the barrier and tape. He has been to many healthcare providers who cannot determine the cause of the irritation. A dermatologist recently took a biopsy of the blister to be examined for bullous pemphigoid. About 3 weeks ago, he was prescribed triamcinolone acetonide cream to use on the irritated skin. Hollister will send out a different barrier product for him to sample.

• Brand Name: NEW IMAGE FLEXTEND PRE SIZED BARRIER
• Type of Device: NEW IMAGE FLEXTEND PRE SIZED 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: 11333193
• MDR Text Key: 232053385
• Report Number: 1119193-2021-00009
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 14703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/12/2021
• 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: Unkown

Patient Treatment Data

Date Received: 02/16/2021 Patient Sequence Number: 1