TRUSCULPT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-13 for TRUSCULPT manufactured by Cutera, Inc..

Event Text Entries

[3242056] Burn.
Patient Sequence No: 1, Text Type: D, B5


[10289483] The actual device was evaluated; the root cause was loss of dielectric contact due to the film lifting.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2954354-2012-00015
MDR Report Key2872552
Report Source07
Date Received2012-06-13
Date of Report2012-06-13
Date of Event2012-05-25
Date Mfgr Received2012-05-25
Date Added to Maude2012-12-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS RENEE LIERLY
Manufacturer Street3240 BAYSHORE BLVD
Manufacturer CityBRISBANE CA 94005
Manufacturer CountryUS
Manufacturer Postal94005
Manufacturer Phone4153575731
Manufacturer G1CUTERA, INC.
Manufacturer Street3240 BAYSHORE BLVD
Manufacturer CityBRISBANE CA 94005
Manufacturer CountryUS
Manufacturer Postal Code94005
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUSCULPT
Generic NameCUTERA CMMCD
Product CodeNUV
Date Received2012-06-13
Returned To Mfg2012-05-25
Model NumberNA
Catalog NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCUTERA, INC.
Manufacturer Address3240 BAYSHORE BLVD BRISBANE CA 94005 US 94005


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-06-13

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