BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERASEED

    MDR report key: 229664 · Received June 5, 1999

    Report

    Report Number
    1057128-1999-00001
    Event Type
    Malfunction
    Date Received
    June 5, 1999
    Date of Event
    April 13, 1999
    Report Date
    June 4, 1999
    Manufacturer
    THERAGENICS CORP
    Product Code
    IWG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO SHIPMENTS WERE REC'D BY THE USER FACILITY, EACH HAVING A DIFFERENT LOT NUMBER. SHIPMENT A CONTAINED THE CALIBRATION SEED FOR SHIPMENT B AND SHIPMENT B CONTAINED THE CALIBRATION SEED FOR SHIPMENT A. THE USER FACILITY DETECTED THE ERROR AND THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASEED BRACHYTHERAPY IMPLANT IWG THERAGENICS CORP MODEL 200 9914F & 9914G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA