BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYTITE PRO WITH BODYTITE HANDPIECE

    MDR report key: 20220333 · Received September 15, 2024

    Report

    Report Number
    3010511300-2024-00496
    Event Type
    Injury
    Date Received
    September 15, 2024
    Date of Event
    October 17, 2022
    Report Date
    September 15, 2024
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    UDI-DI
    07290016633368
    PMA / PMN Number
    K233642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT UNDERWENT BODYTITE PROCEDURE IN 2022 AND SUSTAINED FULL THICKNESS BURNS ON HER RIGHT MEDIAL THIGH. TECHNICAL INSPECTION OF THE SYSTEM DID NOT REVEAL ANY TECHNICAL ISSUES. THE HANDPIECE WAS NOT INSPECTED AS IT WAS DISCARDED BY THE USER. INVESTIGATION ATTRIBUTED THE ROOT CAUSE TO USER ERRORS: THE DOCTOR UTILIZED CUT OFF TEMPERATURES AND TOTAL ENERGY THAT EXCEEDED THE RECOMMENDED LIMITS PER IFU. THIS WAS COMBINED WITH INCORRECT TECHNIQUE: STAMPING ON THE SAME SPOT FOR TOO LONG LEADING TO FULL DEPTH THERMAL INJURY, AND NOT HAVING A GOOD CONTROL OF THE INTERNAL PROBE, DAMAGING THE DERMAL PLEXUS. RETRAINING HAS BEEN SCHEDULED FOR THE CLINIC. THE PATIENT IS CURRENTLY BEING TREATED WITH LASER FOR SCARS AT THE SAME CLINIC.

    Description of Event or Problem · 0

    FULL THICKNESS BURNS ON MEDIAL THIGH POST BODYTITE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667196 BODYTITE PRO WITH BODYTITE HANDPIECE GEI GEI INMODE LTD. AG604881A 07290016633368

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other