BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MA1100-PM

    MDR report key: 4230496 · Received October 8, 2014

    Report

    Report Number
    3003312341-2014-00012
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 8, 2014
    Manufacturer
    THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY
    Product Code
    DWJ
    PMA / PMN Number
    K101705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVAL OF THE UNIT, IT WAS NOTED THAT THE DEVICE ONLY HAD COSMETIC DAMAGE WITH NO FUNCTIONAL DEFECT REPORTED. UPON ATTEMPTING TO OBTAIN FURTHER INFO FROM THE USER FACILITY ON THE ALLEGED BURN EVENT, IT WAS REPORTED THAT THE USER FACILITY DOES NOT HAVE ANY RECORD OF THIS EVENT OCCURRING.

    Description of Event or Problem · 1

    THE UNIT WAS RETURNED FOR REPAIR WITH A NOTE ALLEGING THAT AN EMPLOYEE WAS BURNED. IT WAS NOT REPORTED THAT THE ALLEGED BURN REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630342 MA1100-PM THERMAL REGULATING DWJ THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY MA1100-PM

    Patients

    Seq Age Sex Outcome Treatment
    1