BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRT DELIVERY DEVICE WITH 10 SEED RIBBON

    MDR report key: 381493 · Received March 8, 2002

    Report

    Report Number
    1016427-2002-00035
    Event Type
    Malfunction
    Date Received
    March 8, 2002
    Date of Event
    February 7, 2002
    Report Date
    March 8, 2002
    Manufacturer
    CORDIS CORP.(MIAMI)
    Product Code
    LHN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIST STEPPED THE RIBBON. THE RIBBON SNAPPED NEAR THE WIRE LOCKING MECHANISM AND A SEED FELL ONTO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRT DELIVERY DEVICE WITH 10 SEED RIBBON RADIATION CATHETER LHN CORDIS CORP.(MIAMI) NA 360AB01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN