BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLIPO TRIPLEX PRECISION

    MDR report key: 4640948 · Received March 27, 2015

    Report

    Report Number
    1222993-2015-00009
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 26, 2015
    Product Code
    GEX
    PMA / PMN Number
    K091537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED LIMITED MOTOR SKILLS (DIFFICULTY PURSING ITS LIPS) AFTER THE LIPO CONTOURING LASER TREATMENT. THE PATIENT WAS TREATED ON THE LOWER FACE AND THE NECK AREA USING THE SMARTLIPO TRIPLEX PRECISION DEVICE. THE PATIENT WAS TREATED WITH PREDNISONE TO DECREASE INFLAMMATION ON AFFECTED AREAS. THE LASER WAS OPERATIONAL AND WORKING WITHIN ESTABLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    ADVERSE REACTION TO LASER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207022 SMARTLIPO TRIPLEX PRECISION LASER GEX SMARTLIPO

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability