BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1677123 · Received May 7, 2010

    Report

    Report Number
    1056128-2010-00013
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    April 12, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ASCENT HALTHCARE SOLUTIONS
    Product Code
    NMF
    PMA / PMN Number
    K011832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE INVESTIGATION HAD NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS TESTED BEFORE THE SURGERY AND WAS FOUND TO BE LEAKING. THE DEVICE WAS NOT USED ON THE PATIENT AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NMF NMF ASCENT HALTHCARE SOLUTIONS 11165 880274

    Patients

    Seq Age Sex Outcome Treatment
    1