BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INMODE RF SYSTEM FACE TITE

    MDR report key: 12188979 · Received July 16, 2021

    Report

    Report Number
    MW5102617
    Event Type
    Injury
    Date Received
    July 16, 2021
    Date of Event
    February 11, 2021
    Report Date
    July 15, 2021
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    UDI-DI
    17290016633211
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT RIGHT SIDE OF MOUTH SAGGING POST FACETITE TREATMENT. EVIDENT NEURAPRAXIA IN THE RIGHT LOWER LIP AFTER A FACETITE TREATMENT ON FEBRUARY 11TH. BASED ON OUR PAST EXPERIENCE, IN SUCH CASES, THE NATURE OF THE INJURY IS ALMOST ALWAYS TRANSIENT. DOCTOR (B)(6) REFUSES TO COLLABORATE WITH OUR REPRESENTATIVES AND WOULD NOT FILL IN THE CCQ, NEITHER ACCEPT A TECHNICAL INSPECTION OF THE SYSTEM. MANUFACTURER CASE INVESTIGATION: FURTHERMORE, HE HAS ANNOUNCED THAT HE NO LONGER INTENDS TO USE THIS TECHNOLOGY. THE NEURAPRAXIA THAT OCCURRED IN THIS EVENT MAY HAVE ARISEN FROM AN INVOLUNTARY IMPACT OF THE INSTRUMENT IN THE MANDIBULAR MARGINAL NERVE WHICH IN A CERTAIN POINT ALONG THE MANDIBULAR LINE PROTRUDES IN A SUPERFICIAL POSITION. THIS RESULTS IN A TEMPORARY NEUROPATHY WHICH USUALLY RESOLVES SPONTANEOUSLY WITHIN 2 - 3 MONTHS. IT IS THEREFORE TO BE CONSIDERED A MECHANICAL USER ERROR RELATED TO AN INCORRECT MANEUVER OF THE CANNULA IN THE AREA OF THE PATH OF THE MARGINAL MANDIBULAR NERVE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082279 INMODE RF SYSTEM FACE TITE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INMODE LTD. HP1010306A 20-44 17290016633211

    Patients

    Seq Age Sex Outcome Treatment
    1