BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD 2000 RADIOLUCENT HEADREST SYSTEM

    MDR report key: 2093581 · Received April 19, 2011

    Report

    Report Number
    3004608878-2011-00048
    Event Type
    Other
    Date Received
    April 19, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 19, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A MAYFIELD RADIOLUCENT HEADREST SYSTEM (A2004) WAS INVOLVED IN A SLIPPAGE DURING A PROCEDURE. THE SLIPPAGE WAS FOUND WHEN THE DRAPE WAS REMOVED FROM THE PT. THE PT EXPERIENCED A 1" GASH IN THEIR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD 2000 RADIOLUCENT HEADREST SYSTEM RADIOLUCENT SYSTEMS HBL INTEGRA, CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1