FDA.reportPublic FDA data

MAUDE MDR 7619211

MDR report key
7619211
Report number
MW5077949
Event key
0
Event type
3
Date of event
2017-06-23
Date received
2018-06-19
Adverse event
3
Product problem
0
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 DISRUPTION OF ADIPOCYTE CELLSCYNOSUREPKT* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-1901. O

Event Narratives#

D

Patient 1

I HAD SCULPSURE (A CYNOSURE PROCEDURE) PERFORMED ALMOST A YEAR AGO AND HAD FOUR BIG PROBLEMS WITH IT: IT IS ADVERTISED AS "PAINLESS AND COMFORTABLE." THAT COULDN'T BE FURTHER FROM THE TRUTH. I WENT THROUGH THE WORST CONTRACTIONS YOU CAN IMAGINE WHEN I HAD MY LAST DAUGHTER AND IT IS SIMILAR TO THAT. IT IS PAIN THAT IS PROBABLY A 9 ON A SCALE OF 10. DURING THE PROCEDURE, I DIDN'T THINK I COULD CARRY ON. THE ONLY REASON I WAS ABLE TO IS BECAUSE THERE ARE BRIEF WAVES OF NO PAIN IN BETWEEN THE EXCRUCIATING PAIN; IT LEFT ME WITH PERMANENT SCAR TISSUE. BALLS OF SCAR TISSUE UNDER MY SKIN ON EACH THIGH WHERE I HAD THE PROCEDURE PERFORMED; I WASN'T TOLD THAT I WOULD NEED MULTIPLE PROCEDURES TO SEE RESULTS, BUT AFTER THE FACT WHEN I TOLD THEM ABOUT THE SCAR TISSUE THEY RECOMMENDED I DO THE PROCEDURE AGAIN; THE SCULPSURE YIELDED NO POSITIVE COSMETIC RESULTS WHATSOEVER.