BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLD KNIFE, STRAIGHT BLADE

    MDR report key: 483975 · Received September 10, 2003

    Report

    Report Number
    1519132-2003-00038
    Event Type
    Malfunction
    Date Received
    September 10, 2003
    Date of Event
    August 12, 2003
    Report Date
    September 9, 2003
    Manufacturer
    ACMI NORWALK
    Product Code
    GDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE BLADE BROKE INSIDE THE PATIENT. THE PARTS WERE RETRIEVED AND NO HARM WAS DONE TO THE PATIENT. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLD KNIFE, STRAIGHT BLADE URETHOTOME ACCESSORY GDX ACMI NORWALK K-SB GF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN