BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 2061808 · Received April 4, 2011

    Report

    Report Number
    6000153-2011-02522
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEFT NEEDLE IN THE HANDPIECE UNIT DID NOT RETRACT EVEN AFTER REPOSITIONING. A SECOND HANDPIECE UNIT THEN USED AND THE PROCEDURE WAS COMPLETED. NO INJURIES WERE REPORTED AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1