MAUDE Adverse Event Report: AMENITY HEALTH INC. MEDCLINE ACID REFLUX / GERD PILLOW SYSTEM; SUPPORT PATIENT POSITION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Thrombosis (2100)

Event Date 04/04/2018

Event Type  Injury  

Event Description

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.

• Brand Name: MEDCLINE ACID REFLUX / GERD PILLOW SYSTEM
• Type of Device: SUPPORT PATIENT POSITION
• Manufacturer (Section D): AMENITY HEALTH INC.
• MDR Report Key: 7406243
• MDR Text Key: 104890419
• Report Number: MW5076363
• Device Sequence Number: 1
• Product Code: CCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 44 YR
• Patient Weight: 126