SCULPSURE 105-7026-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-11-22 for SCULPSURE 105-7026-000 manufactured by Cynosure Llc.

MAUDE Entry Details

Report Number1222993-2019-00031
MDR Report Key9364535
Report SourceFOREIGN,OTHER
Date Received2019-11-22
Date of Report2019-11-22
Date of Event2019-10-25
Date Mfgr Received2019-10-25
Device Manufacturer Date2018-11-09
Date Added to Maude2019-11-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street5 CARLISLE ROAD
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 Received2019-11-22
Catalog Number105-7026-000
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCYNOSURE LLC
Manufacturer Address5 CARLISLE ROAD WESTFORD MA 01886 US 01886


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-22

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