BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDSTRAND

    MDR report key: 2192746 · Received June 3, 2011

    Report

    Report Number
    2915056-2011-00001
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Manufacturer
    ANAZAO HEALTH CORP
    Product Code
    KXK
    PMA / PMN Number
    K063177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 IODINE (I-125) SEEDS WERE SUPPLIED FOR IMPLANTATION TO TREAT A PT WITH PROSTATIC CANCER. SEEDS WERE SUPPLIED AS PRE-LOADED NEEDLES WITH A CALIBRATION STRAND. BEFORE IMPLANTATION, THE FACILITY ASSAYED THE SEEDS AND FOUND THE ACTIVITY WAS APPROX 16% LOWER THAN LABELED. DUE TO THE APPARENT DISCREPANCY, THE IMPLANTATION PROCEDURE WAS NOT DONE. QA INVESTIGATION RESULTS ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDSTRAND BRACHYTHERAPY IMPLANT KXK ANAZAO HEALTH CORP 7000

    Patients

    Seq Age Sex Outcome Treatment
    1 NO CONCOMITANT DRUGS REPORTED