BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPERON

    MDR report key: 514978 · Received March 3, 2004

    Report

    Report Number
    1220685-2004-00001
    Event Type
    Other
    Date Received
    March 3, 2004
    Date of Event
    February 4, 2004
    Report Date
    March 2, 2004
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING A CASE, A PT WAS IN THE PRONE POSITION WITH APPROXIMATELY 25 DEGREES OF TRENDELENBURG. A MAYFIELD HEAD CLAMP WAS BEING USED. THE TABLE DRIFTED INTO A FULL TRENDELENBURG AND THE HEAD CLAMP IMPACTED THE FLOOR. THE PT RECEIVED MINOR CONTUSIONS FROM THE IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERON SURGICAL TABLE FQO BERCHTOLD CORP. B810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other