BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCITEOSA

    MDR report key: 13839829 · Received March 21, 2022

    Report

    Report Number
    3017737771-2022-00011
    Event Type
    Injury
    Date Received
    March 21, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 21, 2022
    Manufacturer
    SIGNIFIER MEDICAL TECHNOLOGIES
    Product Code
    QNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER DID NOT REPORT OR HAVE A SERIOUS INJURY. HOWEVER A CONSERVATIVE APPROACH WAS TAKEN TO REPORT THIS EVENT, PLEASE SEE THE ATTACHED RISK ASSESSMENT AND INVESTIGATION REPORT FOR MORE INFORMATION.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT WHILST USING EXCITEOSA, THEIR HEART STARTED BEATING ABNORMALLY, RAPIDLY AND THEY FELT DIZZY. THE PATIENT CALLED AN AMBULANCE AND SPENT SOME TIME WITH THE PARAMEDICS, THE PATIENT DID NOT NEED TO GO TO THE HOSPITAL AND NO TREATMENT OR MEDICATION WAS GIVEN. THE EVENT OCCURRED DURING 'NORMAL USE' AND NO FORESEEABLE MISUSE WAS IDENTIFIED. THERE IS NO DIRECT EVIDENCE THAT EXCITEOSA CAUSED THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35915 EXCITEOSA EXCITEOSA QNO SIGNIFIER MEDICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown