MEDCLINE ACID REFLUX / GERD PILLOW SYSTEM
Received Apr 6, 2018 · Event occurred Apr 4, 2018
Report MW5076363 · MDR key 7406243
Device
Generic name
Support Patient Position
Manufacturer
Amenity Health Inc.Product problems
- Patient-Device Incompatibility
Patient
44 YR
- Pain
- Swelling
- Thrombosis
- Pain
- Swelling
- Thrombosis
Narrative
Description of Event or Problem
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.