BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTOSCAN

    MDR report key: 334671 · Received May 25, 2001

    Report

    Report Number
    8043485-2001-00001
    Event Type
    Death
    Date Received
    May 25, 2001
    Date of Event
    March 24, 1997
    Manufacturer
    ESAOTE S.P.A.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2000, LUNAR CORP. (THE INITIAL IMPORTER AND DISTRIBUTOR OF ESAOTE S.P.A.'S ARTOSCAN ORTHOPEDIC MRI DEVICE) SUBMITTED AN MDR TO THE FDA DESCRIBING THIS EVENT. ESAOTE HAS NOW REVIEWED THE PATIENT'S FILMS AND BELIEVES THE IMAGES DO REVEAL THE PRESENCE OF A TUMOR. IN ANY EVENT, ESAOTE'S INVESTIGATION TO DATE IS CONSISTENT WITH LUNAR'S IN THAT NO MALFUNCTION OF THE DEVICE HAS BEEN REVEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24486 ARTOSCAN ORTHOPEDIC MRI LNH ESAOTE S.P.A. * LANCIO N. 895119, 03/15/95

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death