BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRT DELIVERY DEVICE WITH 10 SEED RIBBON

    MDR report key: 330466 · Received May 4, 2001

    Report

    Report Number
    1016427-2001-00112
    Event Type
    Injury
    Date Received
    May 4, 2001
    Date of Event
    March 8, 2001
    Report Date
    May 4, 2001
    Manufacturer
    CORDIS CORP. (MIAMI)
    Product Code
    LHN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING INTRAVASCULAR BRACHYTHERAPY TREATMENTS, THE ADMINISTERED DOSE WAS 12.5 GRAY (1250 RADS) VERSUS PRESCRIBED DOSE OF 8 GRAY (800 RADS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20626 IRT DELIVERY DEVICE WITH 10 SEED RIBBON RADIATION CATHETERS LHN CORDIS CORP. (MIAMI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN