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 consumer,foreign report with the FDA on 2020-03-11 for SCULPSURE 105-7026-000 manufactured by Cynosure Llc.

MAUDE Entry Details

Report Number1222993-2020-00008
MDR Report Key9820506
Report SourceCONSUMER,FOREIGN
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2020-02-11
Date Mfgr Received2020-02-11
Device Manufacturer Date2017-03-15
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street5 CARLISLE ROAD
Manufacturer CityWESTFORD, MA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCULPSURE
Generic NameSCULPSURE
Product CodePKT
Date Received2020-03-11
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 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2020-03-11

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