BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERASEED

    MDR report key: 3122642 · Received May 17, 2013

    Report

    Report Number
    1037598-2013-00003
    Event Type
    Other
    Date Received
    May 17, 2013
    Date of Event
    March 28, 2013
    Report Date
    May 16, 2013
    Manufacturer
    THERAGENICS
    Product Code
    KXK
    PMA / PMN Number
    K010283
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ORDER FORM INDICATED THE REQUESTED ACTIVITY IN BOTH MCI AND UNITS. THE CUSTOMER SERVICE REP INADVERTENTLY ENTERED THE VALUE FOR MCI INSTEAD OF UNITS AND THE ORDER ENTRY SYSTEM DEFAULTS TO UNITS FOR PD103 ORDERS. THIS RESULTED IN THE ACTIVITY BEING LOWER THAN REQUESTED. THE ERROR WAS NOT DETECTED IN THE ORDER VERIFICATION PROCESS AT TGX NOR DURING THE ORDER CONFIRMATION PROCESS AT THE DISTRIBUTOR, NOR BY THE CUSTOMER UPON RECEIPT AT THE USER FACILITY OR TIME OF IMPLANT.

    Description of Event or Problem · 1

    PROCEDURE WAS AN PD103 PROSTATE BRACHYTHERAPY IMPLANT. THE SEED ORDER WAS FILLED WITH THE INCORRECT SEED ACTIVITY: REQUESTED ACTIVITY = 1.71MCI / 2.21 U. THE ORDER WAS FILLED AT 1.72 U, WHICH IS 22.2% BELOW THE REQUESTED SEED STRENGTH. THE FACILITY CONFIRMED VERBALLY ON (B)(6) 2013 THAT A BOOST DOSE WAS DELIVERED TO THE PT. NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218685 THERASEED RADIONUCLIDE BRACHYTHERAPY SOURCE KXK THERAGENICS 200 1310C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other