FDA.reportPublic FDA data

MAUDE MDR 5266222

MDR report key
5266222
Report number
3010266937-2015-00002
Event key
0
Event type
3
Date of event
2015-11-02
Date received
2015-12-04
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. KEVIN O'BRIEN
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 table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMIAESTHETICS THERMIRFTHERMITIGHT REUSABLE ELECTRODETHERMIAESTHETICSGEIRFE-10-SRFE-10-SNOT REPORTEDR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-0401. R

Event Narratives#

D

Patient 1

PHYSICIAN WAS PERFORMING A THERMITIGHT PROCEDURE ON THE AREA OF A PATIENT'S NECK USING THE THERMIRF GENERATOR WITH THERMITIGHT RE-USABLE ELECTRODE AND DISPOSABLE CANNULA. THE PHYSICIAN CALLED TO REPORT A BURN ON THE PATIENT'S NECK; HE STATED THE INTERNAL TEMP WAS 56-57C AND EXTERNAL WAS ONLY 39C. THERMI CLINICAL SPECIALIST ASKED HOW THE BURN OCCURRED AND THE PHYSICIAN RESPONDED THAT HE WAS NOT SURE. CLINICAL SPECIALIST THEN ASKED IF THE DEVICE TEMPERATURE MIGHT HAVE SPIKED AND WAS NOT GIVEN A RESPONSE. THE LOCATION OF THE BURN ON THE NECK WAS NOT IDENTIFIED INITIALLY. FOLLOW UP WITH THE PHYSICIAN WAS PERFORMED AND HE STATED ON (B)(6) 2015 THAT MEDICAL INTERVENTION WAS PROVIDED IN THE FORM OF TOPICALS TREATMENT AND STERIODS. ADDITIONALLY, THE PHYSICIAN STATED ON (B)(6) 2015 THAT THE DEGREE OF THE BURN WAS AS FOLLOWS: BURN, BLISTER, SCAR, MID NECK BELOW CHIN.