BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHA IV REV. 2 40MM ACTIVE TRANSFER

    MDR report key: 518762 · Received February 6, 2004

    Report

    Report Number
    1062385-2004-00001
    Event Type
    Other
    Date Received
    February 6, 2004
    Date of Event
    January 6, 2004
    Report Date
    January 27, 2004
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE TRANSFER DEVICE SERIAL # ON THE CALIBRATION CERTIFICATE DID NOT MATCH THE SERIAL # OF THE TRANSFER DEVICE THAT WAS RECEIVED AT THE SITE. THE MISTAKE WAS IDENTIFIED BY THE CUSTOMER DURING THE RECEIVING QA PROCEDURES ESTABLISHED FOR HANDLING RADIOACTIVE MATERIALS. THE TRANSFER DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA IV REV. 2 40MM ACTIVE TRANSFER TRANSFER DEVICE MOU NOVOSTE CORP. A1733 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other