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U.S. Department of Health and Human Services

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

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HOLLISTER INCORPORATED NEW IMAGE FLEXTEND PRE SIZED BARRIER Back to Search Results
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.
 
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Brand NameNEW IMAGE FLEXTEND PRE SIZED BARRIER
Type of DeviceNEW 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 Key11333193
MDR Text Key232053385
Report Number1119193-2021-00009
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
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 Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14703
Device Lot NumberUNKNOWN
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 Received02/12/2021
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
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