D
Patient 1
THE UNIT SMELLED LIKE IT WAS BURNING AND FELT HOT.
MAUDE MDR 4445130
- MDR report key
- 4445130
- Report number
- 1723686-2014-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-10-01
- Date received
- 2014-08-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 9990 PARK MEADOWS DR. LONE TREE CO 80124 US
- Phone
- 800-800-8004
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZYNEX | NEXWAVE | ZYNEX MEDICAL | IPF | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-08-05 | 0 | 1. O |
Event Narratives#
N
Patient 1
REPORTING DUE TO A FDA FINDING DURING AN AUDIT IN 01/2014. NO INJURY TO THE PATIENT. CONCLUSION: THE Q28 COMPONENT WAS THE CAUSE OF THE FAILURE.