TRUSCULPT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2013-07-02 for TRUSCULPT manufactured by Cutera, Inc..

Event Text Entries

[45526883] Observations reported from end user: it was reported that two pts, both of who were both treated on the abdomen, had an adverse reactions to the trusculpt procedure while using hand piece (b)(4). The first pt injured by the device had an adverse reaction after 1 of 16 imprints used, whereas the second pt had a 4 distinct reactions (each from individual imprints) out of 32 imprints. Both pts failed to report any pain significantly greater than that experienced during an adverse event free imprint. Engineering observations: the hand piece was first initialized on a system, and the number of treatments remaining was noted. The hand piece had 35 treatments left before it was to be returned for maintenance, indicating that 13 treatments had been delivered prior to the onset of the adverse reactions noted here. Conclusion: while we cannot rule out a bare electrode or excessive perspiration; however, it is unlikely that these two mechanisms initiated electrode failure since the failure occurred subsequently on two different pts. Likely physical damage was the root cause of the failure because not only was the burn in the vicinity of the damage, but spatially coincident with it. Moreover, the burns started occurring after 13 previous treatments. Likely the electrode was damaged after the 13th treatment, but before the 14th. Sweat and partial contact may have exacerbated the film failure.
Patient Sequence No: 1, Text Type: N, H10


[45526884] The pt developed small burns on the abdomen, one burn healed with residual scar.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2954354-2013-00010
MDR Report Key5666164
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2013-07-02
Date of Report2013-06-03
Date of Event2013-05-31
Date Mfgr Received2013-06-03
Device Manufacturer Date2013-03-13
Date Added to Maude2016-05-19
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 ContactMR RENEE LIERLY
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 Received2013-07-02
Device AvailabilityY
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. Deathisabilit 2013-07-02

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