BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTITE

    MDR report key: 21924857 · Received April 29, 2025

    Report

    Report Number
    3010511300-2025-00810
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    December 2, 2024
    Report Date
    April 29, 2025
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY INMODE FOLLOWING PATIENT'S REPORT TO FDA #MW5168036. THE PATIENT COMPLAINED OF A DAMAGE TO HER MEDIAN NERVE FOLLOWING ACCUTITE PROCEDURE. CURRENTLY, INMODE IS PERFORMING ATTEMPTS TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION. NERVE DAMAGE DUE TO INCORRECT WORKING TECHNIQUE IS LISTED AS A POSSIBLE RISK OF THIS TECHNOLOGY. IF ADDITIONAL INFORMATION WILL BE OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    NERVE DAMAGE TO MEDIAN NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192226 ACCUTITE GEI GEI INMODE LTD. UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other