MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-01-08 for ZYNEX manufactured by Zynex Medical, Inc..
[36026601]
Unit was evaluated and no problems was found. Mdr wasn't reported initially due to further investigation and photos not being received. Photos are included.
Patient Sequence No: 1, Text Type: N, H10
[36026602]
Patient reported burn marks on her upper arm. She said she took pictures and will send to us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723686-2016-00003 |
| MDR Report Key | 5366369 |
| Report Source | CONSUMER |
| Date Received | 2016-01-08 |
| Date of Report | 2016-01-08 |
| Date of Event | 2015-01-17 |
| Device Manufacturer Date | 2014-08-13 |
| Date Added to Maude | 2016-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 9990 PARK MEADOWS DRIVE |
| Manufacturer City | LONE TREE CO 80124 |
| Manufacturer Country | US |
| Manufacturer Postal | 80124 |
| Manufacturer Phone | 8004956670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZYNEX |
| Generic Name | COMBO ELECTRICAL STIMULATOR |
| Product Code | IPF |
| Date Received | 2016-01-08 |
| Returned To Mfg | 2015-06-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZYNEX MEDICAL, INC. |
| Manufacturer Address | LONE TREE CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-08 |