TRUSCULPT 3D (21)TS 20454 (01) 00816722021410

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-05 for TRUSCULPT 3D (21)TS 20454 (01) 00816722021410 manufactured by Cutera Inc.

Event Text Entries

[119710796] I had trusculpt 3d on (b)(6) 2018. Was told there would be heat and maybe some redness, later nodule would form but no down time or side effects. I left after the procedure feeling okay. There was a lot of heat and pain during procedure but was told that was normal. The next day i was red and swollen. I was flat on my bed for 3 days before i could even be up for any amount of time. I went back to dr (b)(6) she was shocked. I was burned and extremely injured. She never saw a result like mine. The nodules are red and sensitive to touch. I couldn't bend at the waist without extreme pain. Two weeks later, i am black and blue and sensitive to touch. Nodules are still very large and painful. The nodules are thick and hard. One was about 9" x 7", another 7" x 5" and 5" x 3", and 5" x 2". After 2 weeks they are 2 black spots left and the rest is black and blue. They are finally getting smaller but it will take a long time. No one should be burned and injured like this. Something went very wrong. Dr (b)(6) contacted the company but got no good answers. I did extensive research before getting this done and am disappointed with what happened to me. I saw no bad results anywhere in my research.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079633
MDR Report Key7851054
Date Received2018-09-05
Date of Report2018-08-08
Date of Event2018-07-26
Date Added to Maude2018-09-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTRUSCULPT 3D
Generic NameMASSAGER VAUUM, RADIOFREQUENCY INDUCED HEAT
Product CodePBX
Date Received2018-09-05
Model Number(21)TS 20454
Catalog Number(01) 00816722021410
Lot Number(11) 180611
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCUTERA INC


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-05

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