BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVIG GMBH

    MDR report key: 1772188 · Received July 21, 2010

    Report

    Report Number
    MW5016828
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 21, 2010
    Manufacturer
    MAVIG GMBH
    Product Code
    KPY
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARM BROKE OFF OF THE COLUMN AND HIT THE DR IN THE BACK OF THE HEAD, NECK, AND SHOULDER AREA AND WAS KNOCKED UNCONSCIOUS. ANOTHER PHYSICIAN STEPPED IN TO FINISH THE PROCEDURE WHILE HE WAS TAKEN FOR EXAMINATION. THEY SAID THE PT WAS ALSO HIT BUT NO INJURIES WERE REPORTED AND FURTHER MEDICAL EXAM WAS NOT REQUESTED. NO RECORDS WERE PROVIDED WITH THE DETAILS OF THE DR'S INJURIES. REFERENCED AT (B)(4) UNDER (B)(4). WAITING FOR CUSTOMER TO DO ITS OWN INVESTIGATION, THEN THEY WILL RETURN IT TO US TO DO OUR INVESTIGATION. DATES OF USE: ABOUT 8 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVIG GMBH HANEL ARM KPY MAVIG GMBH OT25U50

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization