BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 203961 · Received December 23, 1998

    Report

    Report Number
    2520313-1998-00053
    Event Type
    Malfunction
    Date Received
    December 23, 1998
    Date of Event
    November 24, 1998
    Report Date
    December 21, 1998
    Manufacturer
    F. WALTER HANEL GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INJECTOR HEAD FELL OFF OF THE OVERHEAD COUNTERPOISE SYSTEM AND WAS CAUGHT BY A TECHNOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVERHEAD COUNTERPOISE SYSTEM OVERHEAD COUNTERPOISE SYSTEM DXT F. WALTER HANEL GMBH OCS115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other