BEUDAMED
    FDA Adverse Event Summary report: N

    EXCITEOSA

    MDR report key: 11831450 · Received May 14, 2021

    Report

    Report Number
    MW5101367
    Date Received
    May 14, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 12, 2021
    Manufacturer
    SIGNIFIER MEDICAL TECHNOLOGIES LLC
    Product Code
    QNO
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER LEFT THEIR CONTROL UNIT TO CHARGE OVERNIGHT WITH THE SUPPLIED USB CABLE. WHEN THEY ATTENDED TO THE CONTROL UNIT AFTER HOURS OF CHARGING (ON (B)(6) 2021), THEY FOUND THAT THE CONTROL UNIT AND CABLE WAS HOT AND HAD MELTED SLIGHTLY AT THE CONNECTION POINT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725655 EXCITEOSA NEUROMUSCULAR TONGUE MUSCLE STIMULATOR FOR THE REDUCTION OF SNORING AND OBSTRUCT QNO SIGNIFIER MEDICAL TECHNOLOGIES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1