BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INMODE RF

    MDR report key: 19788435 · Received July 21, 2024

    Report

    Report Number
    3010511300-2024-00575
    Event Type
    Injury
    Date Received
    July 21, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 19, 2024
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    UDI-DI
    07290016633016
    PMA / PMN Number
    K151793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO TECHNICAL ISSUES WERE FOUND IN THE SYSTEM DURING SERVICE INSPECTION. HP WAS NOT RETURNED FOR INSPECTION. THE INVESTIGATION ATTRIBUTED THE ROOT CAUSE TO USER ERRORS: CUT OFF TEMPERATURES USED WERE ABOVE THE RECOMMENDED PER IFU AND OBVIOUSLY TOO HIGH FOR THE GIVEN THIN FAT LAYER. THE TECHNIQUE ALSO APPEARS TO BE INCORRECT:POOR CONTROL OF TREATMENT DEPTH AND OF THE HP MOVEMENT. THE DOCTOR DECLINED A RETRAINING.

    Additional Manufacturer Narrative · 0

    NO TECHNICAL ISSUES WERE FOUND IN THE SYSTEM DURING SERVICE INSPECTION. HP WAS NOT RETURNED FOR INSPECTION. THE INVESTIGATION ATTRIBUTED THE ROOT CAUSE TO USER ERRORS: CUT OFF TEMPERATURES USED WERE ABOVE THE RECOMMENDED PER IFU AND OBVIOUSLY TOO HIGH FOR THE GIVEN THIN FAT LAYER. THE TECHNIQUE ALSO APPEARS TO BE INCORRECT: POOR CONTROL OF TREATMENT DEPTH AND OF THE HP MOVEMENT. THE DOCTOR DECLINED A RETRAINING. (B)(6) 2024: CORRECTION IS SUBMITTED TO CORRECT H10 (MANUFACTURER NARRATIVE). HANDPIECE NAME WAS ADDED. THE HANDPIECE INVOLVED IN THE INCIDENT WAS FACETITE. NO TECHNICAL ISSUES WERE FOUND IN THE SYSTEM DURING SERVICE INSPECTION. HP WAS NOT RETURNED FOR INSPECTION. THE INVESTIGATION ATTRIBUTED THE ROOT CAUSE TO USER ERRORS: CUT OFF TEMPERATURES USED WERE ABOVE THE RECOMMENDED PER IFU AND OBVIOUSLY TOO HIGH FOR THE GIVEN THIN FAT LAYER. THE TECHNIQUE ALSO APPEARS TO BE INCORRECT: POOR CONTROL OF TREATMENT DEPTH AND OF THE HP MOVEMENT. THE DOCTOR DECLINED A RETRAINING.

    Description of Event or Problem · 0

    FULL THICKNESS BURN ON JOWL.

    Description of Event or Problem · 0

    FULL THICKNESS BURN ON JOWL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483282 INMODE RF GEI GEI INMODE LTD. AG604881A 07290016633016

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other