BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1181726 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04875
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVING THE RX LITHOTRIPTER COMPATABLE BASKET FROM ITS PACKAGING, THE PHYSICIAN NOTED THAT THE TIP OF THE BASKET WAS MISSING AND THE BASKET DID NOT APPEAR TO BE "HELD TOGETHER". THE DEVICE WAS NOT USED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC M00510860 11606987

    Patients

    Seq Age Sex Outcome Treatment
    1