TRUSCULPT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-04 for TRUSCULPT manufactured by Cutera.

Event Text Entries

[4506495] I sought out a solution for a small area around belly button area to reduce appearance of stretch marks. I was recommended a procedure from cutera's trusculpt as a remedy that claims to tighten skin and reduce fat in areas treated. Due to the fact that cost included 16 applications and i only had a small area for 1 application needed, i decided to use device on hips, thighs and over entire abdominal area even though i had very little to no fat in those areas. The device states no side effects and no downtime. Sadly, 7 months later my body has been completely altered in areas treated. I had large bulbous, painful lumps on outer thighs, with severe bruising that is still present, my skin that was once tight and smooth and had no visible fat is now plagued with texture changes including cellulite dimpling and a loose, sagging appearance in all areas treated. All noted by physicians office. I have also fluctuated on my consistent adult life weight of (b)(6) post procedure regardless of eating consumption and not changing my daily workout routine which in itself devastating and uncomfortable with fluid and in my opinion fat gain. I have to present day, since procedure, doubled exercise routine and reduced calorie consumption process in despair of trying to eliminate weight gain from procedure. Cutera failed to report my side effects to fda as well as failed to try and provide a resolution. I have spent countless hours at office who performed procedure to eliminate the awful side effects with little to no improvement and ongoing visible changes to my body. I also had a lymph test performed by physician showing a stagnant lymph system and sought out derma specialists in last 30 days that prescribed and recommended a steroid to help reduce inflammation etc. I have also spent hours and multiple visits on lymph massage, deep tissue massage and acupuncture trying to remedy post procedure effects with little to no improvement. Devastating results and never would have performed if one of my many side effects were listed on consent form. Cutera was notified of my situation numerous times by physician's office and they did not respond as well as failed to report or offer some form of a resolution. Most upsetting is others who have my body type can continue to be harmed by device and consumers should know what temporary or permanent side effects this device may cause so they can make a better educated decision on risks associated with procedure. Instead it was 100% ignored and left unreported by cutera until regency aesthetics and spa reported so others were not damaged and could be educated. I've worked on a healthy lifestyle and daily workouts my whole life and to have this happen as been emotionally devastating. Cutera has been irresponsible and does not seem to care about damaging their consumers and trying to rectify or prevent add'l harm. My once lean, toned body has been altered drastically and continued effects continue to be unknown and only surgery can remedy areas damaged. Same incident as mw5035588.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5036506
MDR Report Key3866727
Date Received2014-06-04
Date of Report2014-06-03
Date of Event2013-12-02
Date Added to Maude2014-06-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTRUSCULPT
Generic NameTRUSCULPT
Product CodePBX
Date Received2014-06-04
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerCUTERA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-06-04

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