MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-23 for ZYNEX IF 8100 manufactured by Zynex Medical.
[1268289]
Patient reported that he suffered three burn marks to the knee. That evening he had blisters. The patient also stated that he saw a spark on one of the four electrodes used.
Patient Sequence No: 1, Text Type: D, B5
[8434537]
Conclusion: the patient is (b)(6) speaking only and this may have contributed to not understanding instructions for usage of the device and the electrode placement or the movement of the electrodes, particularly while the unit is on. Another scenario is that the unit was turned up too high for the patient and caused a more severe reaction to the skin, such as the burn. Corrective action: non required, no problem found with the device or electrodes, user error may have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2009-00003 |
| MDR Report Key | 1408150 |
| Report Source | 07 |
| Date Received | 2009-06-23 |
| Date of Report | 2009-06-23 |
| Date of Event | 2009-06-10 |
| Date Mfgr Received | 2009-06-18 |
| Device Manufacturer Date | 2009-04-08 |
| Date Added to Maude | 2011-03-21 |
| 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 | 8022 SOUTHPARK CIRCLE UNIT 100 |
| Manufacturer City | LITTLETON CO 80120 |
| Manufacturer Country | US |
| Manufacturer Postal | 80120 |
| Manufacturer Phone | 8004956670 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYNEX |
| Generic Name | INTERFERENTIAL ELECTRICAL STIMULATOR |
| Product Code | LIH |
| Date Received | 2009-06-23 |
| Returned To Mfg | 2009-06-18 |
| Model Number | IF 8100 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-06-23 |