BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD

    MDR report key: 3080359 · Received April 22, 2013

    Report

    Report Number
    MW5029919
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 12, 2012
    Report Date
    April 22, 2013
    Manufacturer
    INTEGRA LIFE SCIENCE
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS PLACED IN A MAYFIELD HEADREST BY MD. THE DEVICE WAS LOCKED INTO PLACE AND THEN IT BECAME UNLOCKED CAUSING A LACERATION TO THE PT'S FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173150 MAYFIELD MAYFIELD HEADREST HBL INTEGRA LIFE SCIENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other