BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 1222009 · Received November 6, 2008

    Report

    Report Number
    6000153-2008-07266
    Event Type
    Injury
    Date Received
    November 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    MPROC, VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, PROSTIVA RF MODEL 8929 HAND PIECE NEEDLE RETRACTION FAILURE (2008).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROSTIVA HANDPIECE NEEDLES FAILED TO RETRACT INTO THE CARTRIDGE. THE PATIENT EXPERIENCED SEVERE BLEEDING. THE PROCEDURE WAS ABORTED. FURTHER INFORMATION IS BEING REQUESTED FROM THE MANUFACTURER REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MPROC, VILLALBA 8929 V130401

    Patients

    Seq Age Sex Outcome Treatment
    1