BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERAPY

    MDR report key: 3820091 · Received May 15, 2014

    Report

    Report Number
    MW5036123
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    March 31, 2014
    Product Code
    OHV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS STOPPED ABOUT HALF WAY THROUGH DUE TO MASSIVE BRUISING AND LUMP FORMATION. EVERY WHERE ULTHERAPY WAS USED WAS NOW BLACK. THE ENTIRE AREA WAS VERY SORE (THROAT AND PART OF FACE). LYMPH NODES WERE ENLARGED AND VERY TENDER. AS OF TODAY, (B)(6), THERE CONTINUES TO BE SLIGHT DISCOLORATION AND VERY SLIGHT TENDERNESS. (B)(6), 2014, MET AT MD OFFICE (WITH SMALL GROUP OF LADIES) AND ULTHERAPY (FDA - CLEARED NON-INVASIVE NECK LIFT). DISCUSSED WITH MD AND REP THE DRUG PLAVIX. BOTH SAID PLAVIX WOULD BE NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292091 ULTHERAPY NONE OHV

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NORVASC 5MG| SYSTOLIC 10MG| MULTIVITAMIN| BENICAR| PAXIL 10MG| CALCIUM| VITAMIN E| LOW DOSE ASA| METALONIN 3MG| PLAVIX| ADVAIR| SINGULAIR 10MG| HYDROCHLOROTHIAZIDE 25MG| KLONOPIN 0.5MG FOR SLEEP| VITAMIN C