BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 3775770 · Received April 14, 2014

    Report

    Report Number
    3004106598-2014-00001
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    October 24, 2013
    Report Date
    March 12, 2014
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    OHV
    PMA / PMN Number
    K110306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A CIRCUMFERENTIAL LIPOSUCTION PROCEDURE ON THE THIGHS UTILIZING A SUCTION LIPOPLASTY SYSTEM. PHYSICIAN REPORTS DIMPLING ON THE ANTERIOR LATERAL PORTION OF THE THIGH. PHYSICIAN HAS DECIDED ON A MORE LONG TERM APPROACH FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228622 VASERLIPO SYSTEM SUCTION LIPOPLASTY SYSTEM OHV SOLTA MEDICAL INC. VASER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other