BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH TEMPO 5

    MDR report key: 1070008 · Received July 2, 2008

    Report

    Report Number
    9616099-2008-01667
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K973401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN ITS PACKAGING IS AVAILABLE AND WILL BE RETURN FOR EVALUATION AND TESTING. HOWEVER, THE DEVICE HAS NOT BEEN REC'D AS OF TO DATE.

    Description of Event or Problem · 1

    AS THE SEAL OF THE STERILE PACKAGING WAS OPEN, THE STERILITY OF THE DEVICE COULD NOT BE GUARANTEED. CONSEQUENTLY, THIS DEVICE WAS NOT CLINICALLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH TEMPO 5 DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA 13354745

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK