BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYTITE

    MDR report key: 19803552 · Received July 23, 2024

    Report

    Report Number
    3010511300-2024-00547
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 23, 2024
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    UDI-DI
    07290016633337
    PMA / PMN Number
    K233642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT PRESENTED WITH NEURAPRAXIA OF THE UPPER LIP 1 WEEK POST FACETITE PROCEDURE WITH SENSORY FUNCTIONS INTACT. NO TECHNICAL ISSUES WERE FOUND IN THE SYSTEM DURING SERVICE INSPECTION. THE HANDPIECE WAS NOT RETURNED FOR INSPECTION. TREATMENT SETTINGS WERE CONGRUENT WITH THE PROTOCOL. INVESTIGATION ATTRIBUTED THE ROOT CAUSE TO A USER ERROR: THE OPERATOR WORKED IN THE "NO FLY ZONE", WHERE THE BUCCAL BRANCH OF THE FACIAL NERVE PASSES, CAUSING THE REPORTED NEUROPRAXIA OF THE UPPER LIP. PER LATEST UPDATE FROM THE CLINIC, THE CONDITION IS IMPROVING WITH GRADUAL RESTORATION OF THE MOTOR ACTIVITY OF THE UPPER LIP.

    Description of Event or Problem · 0

    NEUROPRAXIA OF UPPER LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479315 BODYTITE GEI GEI INMODE LTD. AG604881A 07290016633337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other