FDA.reportPublic FDA data

MAUDE MDR 6734496

MDR report key
6734496
Report number
3010266937-2017-00001
Event key
0
Event type
3
Date of event
2017-06-06
Date received
2017-07-21
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 FAY SERA
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 table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMI RADIO FREQUENCY GENERATORRADIO-FREQUENCY ABLATION SYSTEM GENERATORNEUROTHERMGEITHERMIRFY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-2101. R

Event Narratives#

N

Patient 1

THERMIRF GENERATOR WAS EVALUATED ON JULY 19, 2017. ALL PARAMETERS WERE IN CALIBRATION AND GENERATOR TESTING FOUND NO FAILURE. THE THERMAL CAMERA IS ROUTE FOR EVALUATION. THIS ADVERSE EVENT WAS PREVIOUSLY REPORTED BY DR. (B)(6) TO THE FDA (REFERENCE FDA PRP REPORT NUMBER: MW5070816).

D

Patient 1

DR.(B)(6) SENT AN EMAIL COMMUNICATION TO THERMI ON JUNE 8, 2017 IN REGARDS TO A THERMITIGHT PROCEDURE COMPLETED ON THE PATIENT SUBMENTAL REGION. THE DOCTOR INDICATED THE PATIENT RECEIVED SECOND DEGREE BURNS, WHICH THE DOCTOR IS MONITORING AND PROVIDING TREATMENT.