BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 193396 · Received October 22, 1998

    Report

    Report Number
    2520313-1998-00049
    Event Type
    Other
    Date Received
    October 22, 1998
    Date of Event
    October 5, 1998
    Report Date
    October 22, 1998
    Manufacturer
    F. WALTER HANEL, GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HORIZONTAL ARM PORTION DETACHED AT POINT WHERE THE ARM TURNS INTO 360 DEGREE ELBOW. THE HORIZONTAL ARM STRUCK THE TECH IN THE BACK OF THE SHOULDER. TECH IS SORE, BUT OKAY.

    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