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 2019-03-14 for SCULPSURE 105-7026-000 manufactured by Cynosure Inc..

Event Text Entries

[138840360] The patient was then provided with cold packs, antiseptic creams, and local anesthetics for post treatment care. There was no additional information provided by the initial reporter with regard to patient details or treatment parameters. The device was evaluated by a cynosure technician and found the unit to be operable working within specification. We are unable to determine a root cause for the patient's injury. Burns are expected side effects from laser treatment, but due to the severity of a 3rd degree burn, this is a reportable adverse event.
Patient Sequence No: 1, Text Type: N, H10


[138840361] Patient had a 3rd degree burn on the abdomen-flanks area following a laser procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222993-2019-00005
MDR Report Key8422103
Report SourceCONSUMER,FOREIGN
Date Received2019-03-14
Date of Report2019-03-14
Date of Event2018-05-28
Date Mfgr Received2018-12-28
Device Manufacturer Date2016-01-13
Date Added to Maude2019-03-14
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 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 Received2019-03-14
Catalog Number105-7026-000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCYNOSURE INC.
Manufacturer Address5 CARLISLE ROAD WESTFORD MA 01886 US 01886


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-03-14

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