BEUDAMED
    FDA Adverse Event Other Summary report: N

    BUR GUARD

    MDR report key: 461258 · Received May 19, 2003

    Report

    Report Number
    1017294-2003-00027
    Event Type
    Other
    Date Received
    May 19, 2003
    Date of Event
    April 29, 2003
    Report Date
    May 8, 2003
    Manufacturer
    LINVATEC CORP.
    Product Code
    DZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT DISTAL TENDON REPAIR, THE BUR GUARD BECAME HOT WITHIN TEN SECONDS OF ACTIVATION. WHEN THE HEAT WAS NOTICED, THE DEVICE HAD BURNED A VEIN AT THE SURGICAL SITE. NO INTERVENTION WAS REQUIRED. DEGREE OF BURN WAS NOT ESTABLISHED. NO REPORT OF INJURY TO USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR GUARD BUR GUARD DZI LINVATEC CORP. NA APR91

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other