SCULPSURE 100-7026-010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-17 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.

Event Text Entries

[92460362] Following the laser procedure, the thigh area revealed varicose veins, so patient had medical intervention with a vein specialist. The specialist informed the patient that it has a severe venous deficiency and recommended surgery to resolve the issue. There is no evidence that the sculpsure procedure caused the varicose veins to appear, rather this may be a pre-existing condition for the patient. The treatment parameters and technique were followed per the clinical reference guide. The device was evaluated and operated as intended. Pain/discomfort are expected side effects from a laser procedure, however since the patient had medical intervention, this is a reportable event.
Patient Sequence No: 1, Text Type: N, H10


[92460363] Patient had soreness/swelling on the inner thighs from a laser procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222993-2017-00046
MDR Report Key7041791
Report SourceCONSUMER
Date Received2017-11-17
Date of Report2017-11-17
Date of Event2017-09-13
Date Mfgr Received2017-10-27
Date Added to Maude2017-11-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street5 CARLISLE RD
Manufacturer CityWESTFORD MA 01886
Manufacturer CountryUS
Manufacturer Postal01886
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCULPSURE
Generic NameSCULPSURE
Product CodePKT
Date Received2017-11-17
Catalog Number100-7026-010
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCYNOSURE INC
Manufacturer Address5 CARLISLE RD WESTFORD MA 01886 US 01886


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-17

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