BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 485128 · Received September 12, 2003

    Report

    Report Number
    9710053-2003-00005
    Event Type
    Other
    Date Received
    September 12, 2003
    Date of Event
    August 8, 2003
    Report Date
    September 12, 2003
    Manufacturer
    ALM S.A.
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMALL RUBBER END CAP WAS RELEASED FROM ITS POSITION ON THE END OF THE LIGHTHEAD YOKE. IT FELL INTO A PT'S OPENED ABDOMINAL SKIN FLAP AREA, DURING A PROCEDURE. IT IS NOTED THAT ANOTHER SURGICAL LIGHTHEAD WAS BEING MOVED AND CAME IN CONTACT WITH THE RUBBER END CAP, CAUSING ITS RELEASE. THE ATTENDING DOCTOR IMMEDIATELY REMOVED THE RUBBER PART FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LAMP FSY ALM S.A. PRX4401 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other