BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE

    MDR report key: 700520 · Received August 19, 2005

    Report

    Report Number
    3019090-2005-00001
    Event Type
    Other
    Date Received
    August 19, 2005
    Report Date
    July 20, 2005
    Manufacturer
    GETINGE USA
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE FIRST OF 3 MDR'S FOR THE SAME PRODUCT INCIDENT. THE LIGHT CENTER MOUNT SEPARATED FROM ANCHOR PLATE AND DROPPED ONTO OR PERSONNEL AND PATIENT CAUSING INJURY. THE REPORT INDICATED THAT THIS PATIENT SUSTAINED CHEST AND BACK INJURIES. PRODUCT SERVICED ON FEBRUARY 17, 2005 PER FACILITY ADMINISTRATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE SURGICAL LIGHT FSY GETINGE USA 2032 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR