BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGNES RF

    MDR report key: 11669858 · Received April 14, 2021

    Report

    Report Number
    MW5100794
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    February 16, 2021
    Report Date
    April 14, 2021
    Manufacturer
    IAGNES / AGNES RF USA,LLC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT AN ADVERSE REACTION TO AGNES RF RADIOFREQUENCY TREATMENT. PATIENT STATED THAT SHE RECEIVED THE AGNES RF TREATMENT ON (B)(6) 2021 ON HER LOWER JAW LINE. PATIENT STATED THE DEVICE USES LITTLE NEEDLES TO TRANSMIT THE RADIOFREQUENCY. PATIENT SAID SHE HAD SWELLING FOR TWO WEEKS AFTER THE TREATMENT AND THEN HER ENTIRE MIDDLE CHEEK FELL IN. PATIENT STATED WHERE HER CHEEK FELL IN, SHE DID NOT RECEIVE ANY TREATMENT IN THAT AREA. PATIENT STATED HERSELF, AND THE DOCTOR, BELIEVE A RETAINING LIGAMENT IN HER FACE MUST HAVE BEEN HIT DURING THE TREATMENT. PATIENT STATED THAT THE TREATMENT IS NOT SUPPOSED TO GO THAT DEEP, BUT SHE ALSO HAS A DENT BEHIND THE TREATMENT AREA ON HER LOW JAW LINE. PATIENT STATED SHE TOLD THE COMPANY AND INITIALLY THEY WERE RESPONSIVE AND AGREED SOMETHING HAD GONE WRONG WITH HER TREATMENT. HOWEVER, THE PATIENT SAID THEY HAVE GONE SILENT AND SHE'S STILL WAITING TO HEAR BACK FROM A COMPANY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560039 AGNES RF ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI IAGNES / AGNES RF USA,LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR