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..
[36027994]
Patient has been called, and unit has not been received as of (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
[36027995]
Patient reported unit shocks and burns patient when using it. Sales rep believes it is shorting out. He says the unit melt some of the electrodes. The patient claims the lower back garment gave blisters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723686-2016-00001 |
| MDR Report Key | 5366363 |
| Report Source | CONSUMER |
| Date Received | 2016-01-08 |
| Date of Report | 2016-12-08 |
| Date of Event | 2015-12-22 |
| Device Manufacturer Date | 2013-10-23 |
| 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 ELECTRICL STIMULATOR |
| Product Code | IPF |
| Date Received | 2016-01-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |