BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVIG

    MDR report key: 555005 · Received September 13, 2004

    Report

    Report Number
    555005
    Event Type
    Malfunction
    Date Received
    September 13, 2004
    Date of Event
    August 19, 2004
    Report Date
    September 13, 2004
    Manufacturer
    SIEMENS MEDICAL
    Product Code
    IWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    WHEN MOVING THE LEAD SHIELD INTO PLACE DURING A PATIENT PROCEDURE, THE SHIELD DISMANTLED FROM THE BASE ON THE CEILING AND FELL TO THE GROUND STRIKING THE PHYSICIAN USER, CAUSING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVIG LEAD SHIELD IWQ SIEMENS MEDICAL OT256V50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES