BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTANT LINK MAGAZINE

    MDR report key: 1658752 · Received April 9, 2010

    Report

    Report Number
    MW5015517
    Event Type
    Malfunction
    Date Received
    April 9, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 9, 2010
    Manufacturer
    THERAGENICS
    Product Code
    IWG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    INSTANT LINK SEED CARTRIDGE HAD A PRODUCT DEFECT THAT DID NOT ALLOW ALL OF THE SEEDS TO BE RELEASED FROM THE CARTRIDGE FOR IMPLANTATION. THIS RESULTED IN INCREASED OPERATING ROOM TIME AND ANESTHETIC. SEED IMPLANTATION, DISCOVERY OF PROBLEM AND INFORMATION PROVIDED (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTANT LINK MAGAZINE PROSTATE SEED IMPLANT CARTRIDGE IWG THERAGENICS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR