FDA.reportPublic FDA data

MAUDE MDR 5325601

MDR report key
5325601
Report number
3010266937-2015-00004
Event key
0
Event type
3
Date of event
2015-11-12
Date received
2015-12-23
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. 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 THERMIRFTHERMIRFTHERMIAESTHETICSGEITHERMIRFTHERMIRFN/AR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-2301. R

Event Narratives#

D

Patient 1

THE PHYSICIAN PERFORMED A THERMITIGHT PROCEDURE THAT RESULTED IN A BURN TO THE SUBMENTUM. PATIENT HAD SOME FAT BUT NOT A LOT AND LIPO AND THEN THE THERMITIGHT. IT DID WARM TO 43 DEGREES BUT SHE THINKS WHAT HAPPENED IS THAT THE SHE DIDN'T HAVE THE CAMERA IN THE RIGHT PLACE EVEN AFTER LISTENING TO THE WEBINAR. NOW THE PATIENT HAS A DIME SIZE HOLE AND YOU CAN SEE THE FAT. PHYSICIAN PRETTY SURE IT WILL HEAL BY SECONDARY INTENTION BUT IT MAY TAKE A WHILE. INTERVENTION PERFORMED BUT NOT SPECIFIED IN THE REPORT. THE PATIENT HAS VISITED ABOUT 3 TIMES PER WEEK SINCE THE INCIDENT. NO OTHER NOTES PROVIDED.