BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEITEL INJECTION NEEDLE

    MDR report key: 2588489 · Received May 21, 2012

    Report

    Report Number
    MW5025489
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 21, 2012
    Manufacturer
    ENDOCRAFT LLC
    Product Code
    KAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF ZEITERL'S INJECTION NEEDLE BROKE OFF AND EMBEDDED IN PATIENT'S LARYNGEAL TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEITEL INJECTION NEEDLE ZEITEL INJECTION NEEDLE KAA ENDOCRAFT LLC ART-044 REV. F 71296-01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR