BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELASHAPE AND ULTRASHAPE

    MDR report key: 4774378 · Received May 13, 2015

    Report

    Report Number
    3004772125-2015-00001
    Event Type
    Injury
    Date Received
    May 13, 2015
    Date of Event
    April 7, 2015
    Report Date
    May 12, 2015
    Manufacturer
    SYNERON MEDICAL LTD
    Product Code
    NUV
    PMA / PMN Number
    K071872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEWING ALL AVAILABLE DATA AND INFORMATION AT THIS MOMENT IN TIME, THE MOST PROBABLE ROOT CAUSE IS UNK DUE TO LACK OF TREATMENT INFORMATION AND EQUIPMENT INFORMATION. UPON ARRIVAL TESTING OF THE SYSTEM INVOLVED IS PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2015 SYNERON QA WAS MADE AWARE OF A POSSIBLE ADVERSE EVENT THAT OCCURRED TO A PT OF LASER MD MEDSPA. PT REPORTEDLY SUSTAINED BURNS POST TREATMENT WITH ULTRASHAPE TREATMENT FOLLOWED BY VELASHAPE II TREATMENT ON THE ABDOMEN ON THE SAME DAY. PT (B)(6) IS A FEMALE CAUCASIAN PT TREATED ON THE ABDOMEN FOR CIRCUMFERENCE REDUCTION. ULTRASHAPE PROCEDURE HAD THE FOLLOWING SETTINGS: HORIZONTAL TREATMENT WAS USED WITH 8 ACTUAL FOCAL ZONES. PARKER ULTRASOUND GEL WAS USED ALONG WITH STRAPS, AND TRANSDUCER SURFACE APPEARED SMOOTH. VELASHAPE II TREATMENT PARAMETERS ARE UNK AT THIS TIME. POST TREATMENT, PT WAS GIVEN AQUAPHOR WITH NON-STICK GAUZES. PT EXPERIENCED MINOR REDNESS WITHOUT DISCOMFORT AROUND THE BELLY BUTTON AREA DURING ULTRASHAPE PROCEDURE. VELASHAPE II PROCEDURE WAS PERFORMED AFTER, AVOIDING THE BELL BUTTON AREA. FROM PHOTOS TAKEN 1 DAY POST TREATMENT, THE BURNS APPEAR TO BE LOW IN SEVERITY. THE CLINIC STATED THAT THE BURNS WERE FIRST DEGREE BURNS. HOWEVER THE SUBSEQUENT PHOTOS (RECEIVED ON 04/27/2015) SHOW BLISTERS MODERATE IN SEVERITY DURING WHAT SHOULD HAVE BEEN RECOVERY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314164 VELASHAPE AND ULTRASHAPE NONE NUV SYNERON MEDICAL LTD FG71051US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other