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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUTERA TRUSCULPT

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CUTERA TRUSCULPT Back to Search Results
Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problems Emotional Changes (1831); Pain (1994); Swelling (2091); Deformity/ Disfigurement (2360); Weight Changes (2607)
Event Date 12/02/2013
Event Type  Injury  
Event Description

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.

 
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Brand NameTRUSCULPT
Type of DeviceTRUSCULPT
Manufacturer (Section D)
CUTERA
MDR Report Key3866727
MDR Text Key4506495
Report NumberMW5036506
Device Sequence Number1
Product Code PBX
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2014
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Event Location No Information

Patient TREATMENT DATA
Date Received: 06/04/2014 Patient Sequence Number: 1
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