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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER OSTOMY BARRIER

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HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER OSTOMY BARRIER Back to Search Results
Model Number 16107
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Skin Irritation (2076)
Event Date 03/16/2017
Event Type  Injury  
Manufacturer Narrative
The customer reports what appears to be a sensitization to the product. Biocompatibility testing in accordance with iso 10993 has been successfully completed on the barrier material and there was no evidence of sensitization.
 
Event Description
It was reported by the user that she had been using a hollister new image product with tape for approximately 18 months since her stoma surgery. She began experiencing skin irritation which was mainly under the tape. She switched products and for the last seven months she has been using a new image non tape product. The product was not adhering well and she was changing the product daily, making the irritation worse. She went to her doctor and was prescribed steroidal cream and has switched to a new barrier. After the second day now she feels the irritation may be improving.
 
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Brand NameNEW IMAGE FLEXTEND SKIN BARRIER
Type of DeviceOSTOMY BARRIER
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister dr
libertyville IL 60048
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
anne riba
2000 hollister dr
libertyville, IL 60048
8476805625
MDR Report Key6491381
MDR Text Key72778430
Report Number1119193-2017-00011
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 03/16/2017,04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16107
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Home
Date Report to Manufacturer03/16/2017
Date Manufacturer Received03/16/2017
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 Initial

Patient Treatment Data
Date Received: 04/13/2017 Patient Sequence Number: 1
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