MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-03-04 for ZYNEX INWAVE manufactured by Zynex Medical, Inc..
[3193589]
Patient reported she had a burning sensation when using the device at 23ma setting. Could not feel the stimulation at lower settings.
Patient Sequence No: 1, Text Type: D, B5
[10565593]
Patient treated area with pain relief cream. Did not seek professional medical treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2013-00002 |
| MDR Report Key | 2997559 |
| Report Source | 04 |
| Date Received | 2013-03-04 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-02-08 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-03-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 9990 PARK MEADOWS DRIVE |
| Manufacturer City | LONE TREE CO 80124 |
| Manufacturer Country | US |
| Manufacturer Postal | 80124 |
| Manufacturer Phone | 8004956670 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYNEX |
| Generic Name | ELECTRICAL CONTINENCE DEVICE |
| Product Code | KPI |
| Date Received | 2013-03-04 |
| Returned To Mfg | 2013-02-28 |
| Model Number | INWAVE |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZYNEX MEDICAL, INC. |
| Manufacturer Address | LONE TREE CO 80124 US 80124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-04 |