BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARES APNEA RISK EVALUATION SYSTEM

    MDR report key: 7040888 · Received November 16, 2017

    Report

    Report Number
    MW5073391
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 15, 2017
    Manufacturer
    WATER MARK MEDICAL INC.
    Product Code
    BZQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS SENT AN ARES DEVICE THAT YOU WEAR 2 NIGHTS TO TEST FOR SLEEP APNEA. IT INVOLVED A LITTLE MACHINE, WITH TUBING AND A BELT. I WAS TOLD TO WATCH THIS: (B)(6). MY MACHINE HAD ADD'L TUBING AND A BELT, WHICH WAS NOT EXPLAINED IN THE VIDEO. I USED THE DEVICE AND THE 1ST NIGHT I NOTICED MY THROAT WAS SORE, AND THE 2ND NIGHT IT WAS WORSE. WELL TODAY, DAY 3 I AM VERY SICK. I DON'T BELIEVE THE TUBING WAS SANITIZED CORRECTLY. I CALLED THE COMPANY TO COMPLAIN, AND THEY ASSURED ME IT WAS SANITIZED, BUT STILL THERE IS NO OTHER REASON FOR ME TO BE ILL, EXCEPT I WAS GETTING UNSANITARY AIR FROM THE CANNULA. I RETURNED THE DEVICE SO AT THIS POINT YOU WOULD HAVE TO CONTACT THIS COMPANY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815579 ARES APNEA RISK EVALUATION SYSTEM BREATHING FREQUENCY MONITOR BZQ WATER MARK MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability