BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 1202893 · Received October 17, 2008

    Report

    Report Number
    6000153-2008-06626
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MPROC, VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFO IS RECEIVED FROM THE HCP. 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 DID NOT RETRACT INTO THE CARTRIDGE. THE PROCEDURE DID NOT APPEAR AS A MALFUNCTION UNTIL THE HANDPIECE REACHED THE END OF THE PENIS, AND IT STARTED TO CATCH. THE HANDPIECE WAS TAKEN OUT AND THE PROCEDURE WAS COMPLETED WITH A NEW HANDPIECE. THERE WAS SOME BLEEDING AND HEMATURIA. IT WAS EXPECTED THAT THE PT WOULD RECOVER WITHOUT SEQUELA. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MPROC, VILLALBA 8929 V127414

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention