BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL-AIR BASKET BOX OF 5

    MDR report key: 3807719 · Received February 7, 2014

    Report

    Report Number
    3003312341-2014-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 14, 2014
    Report Date
    February 7, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE METAL WIRE ON THE MISTRAL AIR BASKET HAS BECOME SEPARATED FROM THE WELD LEAVING A SHARP ACCESSIBLE EDGE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80710 MISTRAL-AIR BASKET BOX OF 5 THERMAL REGULATING DWJ THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY MA5120-PM

    Patients

    Seq Age Sex Outcome Treatment
    1