BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDCLINE ACID REFLUX / GERD PILLOW SYSTEM

    MDR report key: 7406243 · Received April 6, 2018

    Report

    Report Number
    MW5076363
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    April 4, 2018
    Report Date
    April 5, 2018
    Manufacturer
    AMENITY HEALTH INC.
    Product Code
    CCX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN A USER OF THE MEDCLINE ACID REFLUX/GERD PILLOW SYSTEM (CHECK (B)(6)) FOR ABOUT THREE WEEKS. TWO DAYS AGO I AWOKE WITH A PAIN IN MY LEFT ARM WHERE THE PILLOW SYSTEM RESTS ON MY ARM. THE PAIN GREW PROGRESSIVELY WORSE, AND MY ARM SWELLED AND BECAME HOT TO THE TOUCH. I WENT TO MY PHYSICIAN, WHERE THEY REFERRED ME FOR AN ULTRASOUND AND I WAS ADMITTED TO THE ER. MY DIAGNOSIS WAS A DEEP VEIN THROMBOSIS ("DVT") IN THE LEFT BASILIC VEIN ALONG WITH SUPERFICIAL VEIN THROMBOSIS. I AM CURRENTLY BEING TREATED WITH ELIQUIS, BUT IT IS UNKNOWN IF THERE WILL BE LONG TERM EFFECTS ON MY HEALTH. I AM NOT AWARE OF ANY WARNINGS THAT WERE GIVEN OR THIS COULD BE A SIDE EFFECT OF JUST USING A PILLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244795 MEDCLINE ACID REFLUX / GERD PILLOW SYSTEM SUPPORT PATIENT POSITION CCX AMENITY HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| O