BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSCULPT NEO

    MDR report key: 15210550 · Received August 10, 2022

    Report

    Report Number
    MW5111429
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    December 29, 2021
    Report Date
    August 9, 2022
    Manufacturer
    BTL INDUSTRIES INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EMSCULPT NEO TREATMENT DEVICE CAUSED BURN TO SKIN (MID SUPRAPUBIC WITH A 2 CM OPEN EROSION OF THE SKIN). THE BOTTOM PORTION OF THE DEVICE WAS RESTING ON THE AREA THAT WAS BURNED. THE TREATMENT ALSO CAUSED SUSPECTED ABDOMINAL HEMATOMA - EXTREME TENDERNESS TO PALPITATION OF LOWER RIGHT ABDOMINAL AREA MUSCLE THAT TOOK APPROXIMATELY 10 WEEKS TO RESOLVE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295161 EMSCULPT NEO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BTL INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other JOLESSA BIRTH CONTROL PILL| MULTIVITAMIN