BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERASEED PALLADIUM 103 IMPLANTS

    MDR report key: 298841 · Received September 29, 2000

    Report

    Report Number
    1057128-2000-00001
    Event Type
    Malfunction
    Date Received
    September 29, 2000
    Date of Event
    September 8, 2000
    Report Date
    September 28, 2000
    Manufacturer
    THERAGENICS CORP.
    Product Code
    IWG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    TWO SHIPMENTS WERE RECEIVED BY THE USER FACILITY, EACH HAVING A DIFFERENT LOT NUMBER. SHIPMENT A CONTAINED THE CERTIFICATION STATING PRODUCT IDENTITY FOR SHIPMENT B, AND SHIPMENT B CONTAINED THE CERTIFICATION FOR SHIPMENT A. THE ACTUAL DEVICE LABELS WERE CORRECT. THE USER FACILITY DETECTED THE ERROR, AND THERE WAS NO PT EFFECT. BOTH SHIPMENTS WERE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASEED PALLADIUM 103 IMPLANTS BRACHYTHERAPY IMPLANTS IWG THERAGENICS CORP. MODEL 200 (DEVICE 1) 0034F

    Patients

    Seq Age Sex Outcome Treatment
    1 *