BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE EXTENDER KIT

    MDR report key: 485542 · Received September 17, 2003

    Report

    Report Number
    1519132-2003-00039
    Event Type
    Malfunction
    Date Received
    September 17, 2003
    Date of Event
    August 20, 2003
    Report Date
    September 16, 2003
    Manufacturer
    ACMI NORWALK
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER SAID THAT BLADE EXTENDER FELL OFF DURING THE PROCEDURE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE EXTENDER KIT ACCESSORY OF LARYNGOSCOPE EQN ACMI NORWALK LAR-AE 1128363E OR 1132513E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN