N
Patient 1
THERMIRF GENERATOR WAS EVALUATED ON DECEMBER 6, 2016. ALL PARAMETERS WERE IN CALIBRATION AND WILL BE UNDER FURTHER INVESTIGATION. INVESTIGATION WILL BE ONGOING.
MAUDE MDR 6168061
- MDR report key
- 6168061
- Report number
- 3010266937-2016-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-28
- Date received
- 2016-12-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS TONI FOURNIER
- Address
- 8304 ESTERS BLVD. SUITE 890 IRVING TX 75063 US
- Phone
- 866-866-8669
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | THERMIRF GENERATOR | RADIO FREQUENCY GENERATOR | NEUROTHERM | GEI | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-12 | 0 | 1. R |
Event Narratives#
D
Patient 1
CUSTOMER CALLED STATING A PATIENT SUFFERED A FULL THICKNESS BURN TO THE UNDERARM AFTER THE PROCEDURE ON (B)(6) 2016 AT 11:15 A.M.