N
Patient 1
THERMIRF GENERATOR WAS EVALUATED ON MAY 22, 2018. ALL PARAMETERS WERE IN CALIBRATION AND GENERATOR TESTING FOUND NO FAILURE. THERMAL CAMERA IS ROUTE FOR EVALUATION.
MAUDE MDR 7537171
- MDR report key
- 7537171
- Report number
- 3010266937-2018-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-05-08
- Date received
- 2018-05-23
- 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
- MR. JOHN MCWILLIAMS
- Address
- 3131 WEST ROYAL LANE SUITE 100 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 | ST. JUDE MEDICAL | GEI | THERMIRF | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
PHYSICIAN CALLED STATING PATIENT EXPERIENCED 'FULL THICKNESS BURNS (3 DEGREE)' TO THE SUBMENTAL REGION OF THE NECK AFTER THE PROCEDURE ON (B)(6) 2018.