BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 176077 · Received July 6, 1998

    Report

    Report Number
    2520313-1998-00038
    Event Type
    Malfunction
    Date Received
    July 6, 1998
    Date of Event
    June 17, 1998
    Report Date
    July 1, 1998
    Manufacturer
    F. WALTER HANEL GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE OVERHEAD COUNTERPOISE SYSTEM POST BROKE ALLOWING THE ARM TO FALL. NO INJURY OCCURRED.

    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