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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIOL CO., LTD. SYLFIRM X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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VIOL CO., LTD. SYLFIRM X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Patient Problems Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360)
Event Date 11/08/2023
Event Type  Injury  
Event Description
Minimally invasive- not true because needles go into your skin up to 4mm and the energy goes a millimeter beyond the end of the needle and the sylfirm x has unshielded needles which means that the energy penetrates all layers of the skin all the way down and up.Also this device can vector the skin layers because heat and needles are involved creating scar tissue that according to (b)(6) md is a "grayish porcelain doll look"and unhealthy from day one and collapses in a few years.Minimal downtime - not true because deb sallomi has to have "fat grafting" surgery and has to stay 5 days for the first visit in (b)(6); not including follow ups and a possible 2nd surgery.Also the amount of time it takes to get justice for (b)(6) is a full-time job.Safe and comfortable- not true because it can cause a total melting and shrinking of your face and distorts and fry's your skin in all layers making one's face, neck and chest dysmorphic and devoid of fat pads in your cheeks and large holes ,scarring and divots all over including the face, clavicles and chest making deb prone to getting killed with a paper clip according to (b)(6).(b)(6) breasts fell around 3-4 inches after having her fat removed above her breasts.Psychologically devastating and what dystopian like scottsdale society cynically doesn't allow for any standard of care and protection for the patient? (b)(6) endured a lot of pain even with "pain cream" that had been applied 30 minutes or so and because they said it was safe; deb ignored her body trying to tell her to get up and run from the danger.Immediate results- another big lie- you don't know if your fat was melted for up to 12 weeks or more because if apoptosis has been triggered for an orderly cellular destruction instead of necrosis: you won't know until well after the 2nd or third treatment because sylfirm x via (b)(6) and the omni aesthetics in (b)(6) who trains sylfirm x and morpheus users says to wait only 3-4 weeks between treatments which is way too soon.Improves skin complexion- not true because (b)(6) now has skin laxity due to a 30% loss of volume, rhytids, all fat vaporized which actually makes collagen is now gone aging (b)(6) 40 years or more.(b)(6) has deep burn type scaring in a rectangular and conical shape as well as a complete distortion of her muscles and a dysmorphic and aged look which looks nothing like her x factor beauty.(b)(6) md said that (b)(6) will never look the same even with fat grafting.(b)(6) looks like she has been in a car wreck, bomb blast, gunshot, cancer surgery or sylfirm x!.Minimizes the appearance of scars- not true because it creates maximum deep burn type scars all over including the cheeks, around the clavicles and everywhere and sylfirm's brochure talks about operator error as a known variable that's up to the consumer to check out the operator's previous results or you can have a really bad result.So the results are very inconsistent which is why (b)(6) a dermatologist that has seen (b)(6) for 50 minutes stated as why she doesn't have any rf type micro needling devices.I have not found any plastic surgeons to have these type of electro coagulation hemostasis blood vessel and cellular destruction devices that are used off label from the fda approval.Improves skin texture and tone- not true- ages the skin 40 years and creates a greyish tone with skin laxity, scarring, rhytids, a massive reduction in collagen by melting all of the youthful fat that creates collagen.Creates a pitted and dysmorphic appearance destroying and melting (b)(6) chin about one inch and shrunk her face by at least 30%.Improves skin revitalization- not true and completely deconstructs and destabilizes the entire skin area from all three layers of skin and the muscles and destroys the fat and destroys the youthful appearance permanently and not just one year or less.The sylfirm x has permanently melted all of the fat in (b)(6) face, neck and chest and disfigured her and shrunk her face about 30% and the above comments are about the sylfirm x misinformation poster in the office of vitality md's at (b)(6) at (b)(6) said that their aestheticians are artists because they vector your body to form a new face so it's mostly a skill that has to be obtained and not a consistent result so "buyer beware".Also they push a 3-4 week interval between treatments so as to not allow apoptosis to show up.The sylfirm x should be removed immediately from the market because (b)(6) md who purchased the machine will not offer the "fat grafting" to repair (b)(6) but only offers to refund the (b)(6) and continues to offer this electro coagulation hemostasis vascular destruction device on peoples faces that are smokers taking fish oil and a 19% body fat and who are post menopausal.In (b)(6) you only need 2 years of high school and $40 and (b)(6) was a "lab rat" for (b)(6) on (b)(6) 2023 and (b)(6) 2023.Nonstandard of care and no supervision and no recourse and no reporting to the fda about adverse effects.Please remove the sylfirm x.Plastic surgery is being performed and this machine is definitely mislabeled as cosmetic but really a surgical device with permanent results."it's very o.".
 
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Brand Name
SYLFIRM X
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
VIOL CO., LTD.
MDR Report Key18704210
MDR Text Key335461671
Report NumberMW5151567
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Patient Sequence Number1
Treatment
AMBIEN; AMBIEN; D PLUS K; DHEA; ESTRADIOL; ESTROGEN; LEVOTHYROXONE; MAGNESIUM FISH OIL; MAGNESIUM LEXAPRO; PROGESTERONE; SUBOXONE; TESTOSTERONE; TIZANADINE; TRILOGY; TYLENOL; WELLBUTRIN
Patient Outcome(s) Other;
Patient Age62 YR
Patient SexFemale
Patient Weight51 KG
Patient EthnicityNon Hispanic
Patient RaceAmerican Indian Or Alaskan Native, White
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