BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELASHAPE III

    MDR report key: 7544455 · Received May 25, 2018

    Report

    Report Number
    3003772750-2018-00001
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    April 18, 2018
    Report Date
    May 24, 2018
    Manufacturer
    SYNERON MEDICAL LTD.
    Product Code
    NUV
    UDI-DI
    07290109952031
    PMA / PMN Number
    K122579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER INVESTIGATION.

    Description of Event or Problem · 1

    FEMALE PATIENT (B)(6) YEARS OLD WITH SKIN TYPE 3 UNDERWENT ULTRASHAPE POWER AND VELASHAPE COMBINED TREATMENT ON (B)(6) 2018 ON THE INNER THIGH AREA. ACCORDING TO THE PATIENT, THE VELASHAPE TREATMENT WAS PERFORMED FOR 10 MIN AT 43 DEGREES FOLLOW BY A TREATMENT WITH ULTRASHAPE POWER. NO BURNING WAS OBSERVED AFTER THE VELASHAPE TREATMENT. DURING THE ULTRASHAPE TREATMENT THE CUSTOMER INDICATED THAT THE PATIENT FELT A LITTLE MORE HEAT, BUT DID NOT COMPLAIN OF BURNING. WHEN THE TREATMENT WAS OVER, THE SKIN WAS A LITTLE RED BUR NOT BROKEN. ON (B)(6) 2018, PATIENT COMPLAINED ABOUT BURN ON THE INNER THIGH AREA. THE COMPANY MADE MULTIPLE ATTEMPTS TO REACH PATIENT, HOWEVER WE WERE NOT ABLE TO GET ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387623 VELASHAPE III VELASHAPE III NUV SYNERON MEDICAL LTD. 07290109952031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other