FDA.reportPublic FDA data

MAUDE MDR 7510618

MDR report key
7510618
Report number
MW5077173
Event key
0
Event type
3
Date of event
2018-04-30
Date received
2018-05-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTRASHAPEFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTIONSYNERON MEDICAL LTD.OHVI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-1101. R

Event Narratives#

D

Patient 1

I WAS BADLY BURNED ALL OVER MY ABDOMEN FROM A FAT REDUCTION MACHINE CALLED ULTRASHAPE. I WAS TOLD THERE WAS ONLY A 1 PERCENT CHANCE OF THIS HAPPENING.