BEUDAMED
    FDA Adverse Event Other Summary report: N

    MD TECH

    MDR report key: 202904 · Received December 18, 1998

    Report

    Report Number
    202904
    Event Type
    Other
    Date Received
    December 18, 1998
    Date of Event
    December 15, 1998
    Report Date
    December 16, 1998
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES
    Product Code
    IWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROSTATE SEED IMPLANT PROCEDURE THE IMPLANT NEEDLE BEING INSERTED BROKE OFF, LEAVING 3.5CM OF NEEDLE IN PROSTATE. THE PT AND HIS WIFE WERE INFORMED OF NEEDLE TIP REMAINING IN PROSTATE GLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD TECH PROSTATE SEEDING SET P.S.S. IWF MEDICAL DEVICE TECHNOLOGIES REF: 500518200 81048564

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other