SCULPSURE 100-7026-010 105-7026-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-11-01 for SCULPSURE 100-7026-010 105-7026-000 manufactured by Cynosure Inc..

Event Text Entries

[125906263] Cynosure's clinical team was unable to obtain patient/treatment details to further investigate this incident as the customer site was unresponsive to multiple requests for information. A recent device evaluation found the unit operating as intended and working within specification. Cynosure is unable to determine how the patient experienced a kidney infection following a laser procedure, but we intend to report this as an adverse event.
Patient Sequence No: 1, Text Type: N, H10


[125906264] Patient claimed of an alleged kidney infection following a laser procedure. (patient 2 of 2).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222993-2018-00026
MDR Report Key8031047
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2018-11-01
Date of Report2018-11-01
Date of Event2018-07-02
Date Mfgr Received2018-10-05
Device Manufacturer Date2017-07-25
Date Added to Maude2018-11-01
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 01886
Manufacturer CountryUS
Manufacturer Postal01886
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCULPSURE
Generic NameSCULPSURE
Product CodePKT
Date Received2018-11-01
Model Number100-7026-010
Catalog Number105-7026-000
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 2018-11-01

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