BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 94967 · Received May 27, 1997

    Report

    Report Number
    2520313-1997-00019
    Event Type
    Malfunction
    Date Received
    May 27, 1997
    Date of Event
    April 28, 1997
    Report Date
    May 26, 1997
    Manufacturer
    HANEL GMBH
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE OVERHEAD COUNTERPOISE SYSTEM'S (OCS) VERTICAL ARM SEPARATED AND FELL FROM THE SYSTEM WHILE MOVING THE OCS. NO INJURY RESULTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA