MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-06-16 for ZYNEX IF 8000 manufactured by Zynex Medical.
[1265952]
A person reported that his client suffered several burns to the knee after using our device.
Patient Sequence No: 1, Text Type: D, B5
[8438092]
The patient in question was not in our records database nor did we find any physician's prescription on this person. The person reporting this event did not give us his phone number or the number of the patient. Attempts to find them was not successful. No device was returned for evaluation. No other events such as a number of burns to the skin have been reported on this device. This is being reported at the recommendation of (b)(4), fda investigator after an inspection of zynex medical on 6/3/09 - 6/10/09.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2009-00001 |
| MDR Report Key | 1403893 |
| Report Source | 99 |
| Date Received | 2009-06-16 |
| Date of Report | 2009-06-16 |
| Date of Event | 2007-12-10 |
| Date Added to Maude | 2010-08-21 |
| 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 | 8022 SOUTHPARK CIR, UNIT 100 |
| Manufacturer City | LITTLETON CO 80120 |
| Manufacturer Country | US |
| Manufacturer Postal | 80120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYNEX |
| Generic Name | INTERFERENTIAL ELECTRICAL STIMULATOR |
| Product Code | LIH |
| Date Received | 2009-06-16 |
| Model Number | IF 8000 |
| 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 |
| Manufacturer Address | LITTLETON CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-16 |