FDA.reportPublic FDA data

MAUDE MDR 7868688

MDR report key
7868688
Report number
MW5079714
Event key
0
Event type
3
Date of event
2018-04-19
Date received
2018-09-11
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
1SCULPSURELASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USECYNOSURE INC.PKTI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-110

Event Narratives#

D

Patient 1

I CAN'T REMEMBER THE EXACT DATE - (B)(6) OR EARLY (B)(6), I HAD SCULPSURE DONE ON MY INNER THIGHS IN (B)(6). AFTER 6 WEEKS, NO RESULT. AFTER 12 WEEKS, IT SEEMED THAT MY FAT WAS JUST LUMPY AND MY SKIN MORE "ZIGGLEY." THE PROCEDURE WAS EXTREMELY PAINFUL AND 6 MONTHS LATER, I STILL FEEL TINGLING. I FEEL I HAVE SOME NERVE DAMAGE OR CONNECTIVE TISSUE DAMAGE BUT NO EVIDENCE OF FAT LOSS. THERE IS NO IMPROVEMENT IN SIZE OR SKIN TONE. I PAID OVER (B)(6). THIS PROCEDURE AS WELL AS OTHER FAT LOSS TREATMENT DON'T SEEM TO WORK AND THEY MAY BE DETRIMENTAL. I FEEL DUPED AND EMBARRASSED. WHY DO YOU ALLOW THIS? IT'S CONSUMER FRAUD AND DOCTORS GET PAID NO MATTER WHAT. THIS PROCEDURE DOES NOT WORK.