BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO MED

    MDR report key: 3151735 · Received June 3, 2013

    Report

    Report Number
    MW5030440
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PROMED
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE MAYFIELD HEADHOLDER WAS PLACED ON THE PT'S HEAD, BUT IT SLIPPED OUT OF PLACE BEFORE ACTUALLY TURNING TO POSITION PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242538 PRO MED DORO TEFLON SKULL CLAMP HBL PROMED

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR