BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODY TITE

    MDR report key: 17833677 · Received September 27, 2023

    Report

    Report Number
    MW5146219
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    October 4, 2022
    Report Date
    September 24, 2023
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022 LIPOSUCTION AND SCULPTING OF ABDOMEN, FLANK AND BACK WAS PERFORMED BY DR. (B)(6). BODY TITE AND J PLASMA WERE USED DURING THIS SURGERY. IMMEDIATELY AFTER, I HAD BURNING OF THE SKIN, BROWN HYPERPIGMENTATION, INFLAMMATION, WATER RETENTION AND SCARRING. AFTER MULTIPLE CORRECTIVE MEASURES, SKIN IS CURRENTLY STILL HYPERPIGMENTED AND WRINKLED LOOKING. REFERENCE REPORT: MW5146220.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 10/30/2023 FOR REPORT MW5146219 TO CHANGE THE MFR TO INMODE LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100020 BODY TITE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INMODE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability