MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-06 for MEDCLINE ACID REFLUX / GERD PILLOW SYSTEM manufactured by Amenity Health Inc..
[104890419]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076363 |
| MDR Report Key | 7406243 |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-04-04 |
| Date Added to Maude | 2018-04-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDCLINE ACID REFLUX / GERD PILLOW SYSTEM |
| Generic Name | SUPPORT PATIENT POSITION |
| Product Code | CCX |
| Date Received | 2018-04-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMENITY HEALTH INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2018-04-06 |