BEUDAMED
    FDA Adverse Event Summary report: N

    FRACTORA DEVICE

    MDR report key: 8213395 · Received January 2, 2019

    Report

    Report Number
    MW5082793
    Date Received
    January 2, 2019
    Date of Event
    September 13, 2018
    Report Date
    December 30, 2018
    Manufacturer
    INMODE MD LTD
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TRAINING, THE PATIENT WAS TREATED AT RECOMMENDED SETTINGS PER QRG 20-30 POWER WITH UNCOATED PIN (SKIN TYPE III), SINGLE PULSE 290 PULSES. NECK HEALED WELL WITH NO ISSUES. DURING THE TRAINING THEY EXPRESSED THAT THEY WOULD BE TREATING UNDER IV SEDATION AT HIGHER SETTINGS WHILE THE DR. WAS NOT PRESENT. THEN THE DR. TREATED THE PATIENT UNDER IV SEDATION 45-55 POWER. THREE (3) DAYS POST TREATMENT PATIENT REPORTS UNUSUALLY SEVERE SWELLING, SEVEN (7) DAYS POST TREATMENT PATIENT REPORTS INFLAMMATORY LESIONS. FOUR (4) WEEKS POST TREATMENT PICTURES SHOW PITTING SCARS AND HYPERPIGMENTATION OVER THE FACE AND A DERMATITIS-LIKE RESPONSE ON THE NECK. ACCORDING TO THE DEVICE USER MANUAL SUCH INCREASE IN POWER SHOULD BE PRIMED WITH A TEST SPOT PRIOR TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3179 FRACTORA DEVICE ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI INMODE MD LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR