BEUDAMED
    FDA Adverse Event Summary report: N

    ACUTRAK

    MDR report key: 1652129 · Received March 22, 2010

    Report

    Report Number
    1652129
    Date Received
    March 22, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 22, 2010
    Manufacturer
    ACUMED, INC.
    Product Code
    HXX
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCREWDRIVER WAS USED TO REMOVE SCREW FROM PREVIOUS SURGERY. SCREWDRIVER HEAD SPLINT IN TWO AND TINY METAL FRAGMENTS COULD NOT BE REMOVED FROM PATIENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NOT KNOWN====================== MANUFACTURER RESPONSE FOR SCREWDRIVER, ACUTRAK SCREWDRIVER======================NOT KNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUTRAK SCREWDRIVER, HEX HXX ACUMED, INC. NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR