BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA 2.5MM HEX DRIVER

    MDR report key: 506175 · Received December 22, 2003

    Report

    Report Number
    1725057-2003-00003
    Event Type
    Malfunction
    Date Received
    December 22, 2003
    Date of Event
    August 6, 2003
    Report Date
    December 19, 2003
    Manufacturer
    U&I CORP., AMERICA
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA 2.5MM HEX DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXX U&I CORP., AMERICA SP00005-US 02G324

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other