FDA.reportPublic FDA data

MAUDE MDR 7406243

MDR report key
7406243
Report number
MW5076363
Event key
0
Event type
3
Date of event
2018-04-04
Date received
2018-04-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDCLINE ACID REFLUX / GERD PILLOW SYSTEMSUPPORT PATIENT POSITIONAMENITY HEALTH INC.CCXI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-0601. H; 2. L; 3. O

Event Narratives#

D

Patient 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.