TRUSCULPT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-04 for TRUSCULPT manufactured by Cutera, Inc.

Event Text Entries

[81894635] Partial thickness burn with slow wound healing. The wound is in a cosmetically sensitive area. The slow wound healing increases the risk for scar formation. The root cause of the burn is user error. The device operator treated over a contraindicated area. There is not a device performance complaint associated with the clinical event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2954354-2017-00002
MDR Report Key6769344
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-08-04
Date of Report2017-07-19
Date of Event2017-06-30
Date Mfgr Received2017-07-19
Device Manufacturer Date2017-03-06
Date Added to Maude2017-08-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS RENEE LIERLY, R.N.
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
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameTRUSCULPT
Generic NameRADIO FREQUENCY INDUCED HEATING
Product CodePBX
Date Received2017-08-04
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCUTERA, INC
Manufacturer Address3240 BAYSHORE BLVD BRISBANE CA 94005 US 94005


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-08-04

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