TRUSCULPT TXH10009

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-29 for TRUSCULPT TXH10009 manufactured by Cutera.

Event Text Entries

[16449838] Device operator intended to perform a procedure in the submentum area. The device operator inadvertently included tissue of the upper, anterior neck in the procedure area. Electrode placement error. The patient developed a blister on the anterior of the neck. There were no adverse events in the submentum area. The patient did not report the blister to the user facility until 5 days after the procedure. The patient presented with approximately a 6mm wound with signs of localized infection (redness, drainage and swelling). The physician prescribed oral antibiotics. The wound was not cultured. Wound closed and healed; redness is slowly resolving without medical intervention. The device was not returned to cutera. The device has been used to perform procedures on other patients with no report of adverse events.
Patient Sequence No: 1, Text Type: D, B5


[16688918] The device has not been returned to the mfr for evaluation. The device has been used to perform procedures on other patient's with no report of adverse events.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2954354-2013-00022
MDR Report Key3547967
Report Source06
Date Received2013-10-29
Date of Report2013-09-30
Date of Event2013-09-25
Date Mfgr Received2013-09-30
Device Manufacturer Date2013-07-22
Date Added to Maude2014-01-03
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 FDA0
Event Location3
Manufacturer ContactMS RENEE LIERLY
Manufacturer Street3240 BAYSHORE BLVD
Manufacturer CityBRISBANE CA 94005
Manufacturer CountryUS
Manufacturer Postal94005
Manufacturer Phone4156575731
Manufacturer G1CUTERA
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 Received2013-10-29
Model NumberNA
Catalog NumberTXH10009
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCUTERA
Manufacturer Address3240 BAYSHORE BLVD BRISBANE CA 94005 US 94005


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-10-29

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