BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOSMART PROGUIDE SHARP NEEDLE

    MDR report key: 1621157 · Received February 4, 2010

    Report

    Report Number
    9611894-2010-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    October 23, 2009
    Report Date
    February 2, 2010
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    PMA / PMN Number
    K060349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONCOSMART PROGUIDE SHARP NEEDLE BROKE IN HALF INSIDE THE PT DURING A PROSTATE TREATMENT. IT WASN'T NOTICED UNTIL THE PT WENT HOME AND THEN CAME BACK COMPLAINING ABOUT DISCOMFORT. THE PT WAS THEN CT'D AND THE NEEDLE WAS DISCOVERED. IT HAD TO BE REMOVED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOSMART PROGUIDE SHARP NEEDLE JAQ, HDR REMOTE AFTERLOADING ACCESSORY JAQ NUCLETRON BV 189617 092719

    Patients

    Seq Age Sex Outcome Treatment
    1