BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSCULPT 3D

    MDR report key: 11869813 · Received May 21, 2021

    Report

    Report Number
    MW5101486
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    February 15, 2019
    Report Date
    May 19, 2021
    Manufacturer
    CUTERA INC
    Product Code
    PBX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD 3 ROUNDS OF TRUSCULPT, THE 1ST WAS 3D AND THEN MY PROVIDER UPGRADED TO THE ID. (B)(6) 2019, (B)(6) 2019, (B)(6) 2019 I HAVE BEEN LEFT WITH AN INDENTATION ON THE LEFT SIDE OF MY ABDOMEN AND LOOSE SKIN. MY PROVIDER DOESN'T SEEM CONCERNED. MY BELLY CHANGED BUT NOT FOR THE BETTER AS I AM NOW ALL LOPSIDED. ALMOST SEEMS LIKE I MIGHT NEED TO UNDERGO SOME LIPOSUCTION TO FIX IT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761422 TRUSCULPT 3D MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT PBX CUTERA INC
    761423 ID MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT PBX CUTERA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR