BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 160767 · Received March 30, 1998

    Report

    Report Number
    2520313-1998-00014
    Event Type
    Malfunction
    Date Received
    March 30, 1998
    Date of Event
    February 25, 1998
    Report Date
    March 25, 1998
    Manufacturer
    F. WALTER HANEL GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE OVERHEAD COUNTERPOISE SYSTEM POST BENT AND EVENTUALLY BROKE. 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