BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 499364 · Received October 27, 2003

    Report

    Report Number
    499364
    Event Type
    Malfunction
    Date Received
    October 27, 2003
    Date of Event
    July 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    REMINGTON MEDICAL INC.
    Product Code
    IWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PROSTATE SEEDING NEEDLE WAS NOTED TO HAVE MARKINGS DIFFERENT FROM NORMAL. THE MARKINGS ARE PRESENT TO ALLOW THE USER TO KNOW HOW DEEP TO PLACE THE SEED. THE NEEDLE HAD ABOUT DOUBLE THE USUAL DISTANCE TO THE FIRST MARK. IF USED, THE SEED WOULD NOT HAVE BEEN PLACED IN THE PROPER LOCATION. THE NEEDLE WAS NOT USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROSTATE SEEDING NEEDLE IWJ REMINGTON MEDICAL INC. PSS-1820 EITHER 022681 OR 020535

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other