BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    INMODE LTD

    MDR report key: 16384841 · Received February 16, 2023

    Report

    Report Number
    3010511300-2023-00045
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    June 25, 2021
    Report Date
    June 25, 2021
    Manufacturer
    INMODE LTD
    Product Code
    PBX
    UDI-DI
    07290016633542
    PMA / PMN Number
    K191855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS TESTED, AND NO ANOMALIES WERE FOUND. SERVICE INSPECTION SHOWED THAT THE SYSTEM WORKS ACCORDING TO SPECIFICATIONS. SUMMARY OF RELATED INVESTIGATIONS THE EVENT WAS RESULT OF A TRIPLE FAULT CONDITION, CHARACTERIZED BY EXTREMELY LOW PROBABILITY: 1. APPLICATOR WAS PLACED UNPROPERLY IN A WAY THAT PART OR THE WHOLE APPLICATOR WAS IN THE AIR AND MISLEAD TEMPERATURE SENSORS. 2. SINCE TECHNICAL INSPECTION DID NOT REVEAL ANY FAILURE IN PATIENT CALL BUTTON, THE ONLY PLAUSIBLE EXPLANATION IS THE PATIENT NOT PRESSING THE BUTTON ALL THE WAY. 3. TREATMENT ATTENDANT WAS NOT IN THE ROOM DESPITE CLEAR INSTRUCTION IN THE IFU NOT TO LEAVE THE PATIENT UNATTENDED, AND COULD NOT HELP THE PATIENT BY REMOVING THE MASK OR PRESSING DEVICE OFF BUTTON TO DISABLE THE DEVICE. AFTER REVIEWING OF SAFETY RECORD FOR ABOUT 500 DEVICES INSTALLED AROUND THE WORLD THE COINCIDENCE OF THESE CIRCUMSTANCES LOOKS EXTREMELY LOW.

    Description of Event or Problem · 0

    FULL THICKNESS (3RD STAGE) BURN ON RIGHT CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385564 INMODE LTD EVOKE CHEEK PBX INMODE LTD AG608275A 07290016633542

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention