TRUSCULPT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-08-05 for TRUSCULPT manufactured by Cutera, Inc..

Event Text Entries

[4085420] Pt experienced a burn in the area that the procedure was performed. The device was returned to the mfr, evaluated and found to have damage to the patient contact surface of the rf electrode. The damage is consistent with mechanical scrapping damage and compression damage to the surface. The damage to the surface of the electrode is visible and easily detectable by the device operator by visual inspection. The patient outcome is unk, the patient did not return for follow up eval.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2954354-2013-00015
MDR Report Key3481494
Report Source99
Date Received2013-08-05
Date of Report2013-07-08
Date of Event2013-06-17
Date Mfgr Received2013-07-08
Device Manufacturer Date2013-05-26
Date Added to Maude2013-11-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactMS RENEE LIERLY, RN
Manufacturer Street3240 BAYSHORE BLVD
Manufacturer CityBRISBANE CA 94005
Manufacturer CountryUS
Manufacturer Postal94005
Manufacturer Phone4156575731
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 NameMASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
Product CodePBX
Date Received2013-08-05
Returned To Mfg2013-07-18
Model NumberNA
Device AvailabilityR
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 2013-08-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.