BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOTOWER WITH ASPIRATION AND INFILTRATION

    MDR report key: 5039419 · Received August 28, 2015

    Report

    Report Number
    2020601-2015-00051
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    July 10, 2015
    Report Date
    August 28, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    MUU
    PMA / PMN Number
    K150779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO INDICATIONS OF AN OUT OF BOX FAILURE, THE INCIDENT WAS DETERMINED TO BE REPORTABLE.

    Description of Event or Problem · 1

    IT APPEARS THAT THE WIRING ON THE FRONT PANEL IS NOT CORRECT. THIS WAS AN OUT OF BOX FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572969 LIPOTOWER WITH ASPIRATION AND INFILTRATION LIPOTPWER MUU MICROAIRE SURGICAL INSTRUMENTS ASP-1021 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1