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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD DAVOL XEN MATRIX AB

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BARD DAVOL XEN MATRIX AB Back to Search Results
Device Problem Material Deformation (2976)
Patient Problems Pain (1994); Disability (2371)
Event Date 04/01/2016
Event Type  Injury  
Event Description
Xen matrix ab was used in bilateral reconstruction with tram flap and umbilical hernia repair. Mesh has hardened into a "bone like" matter and has caused excruciating pain and disability. Subsequent surgeries performed and extensive lifestyle limitation has occurred.
 
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Brand NameXEN MATRIX AB
Type of DeviceXEN MATRIX AB
Manufacturer (Section D)
BARD DAVOL
MDR Report Key6543624
MDR Text Key74541994
Report NumberMW5069553
Device Sequence Number1
Product Code FTM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: NA; RX MEDS: ZOLPIDEM 10 MG
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