MAUDE Adverse Event Report: REJUVATEK MEDICAL INC. MASSIVE DELIVERY SYSTEM; POWERE LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tissue Damage (2104)

Event Date 10/25/2017

Event Type  Injury  

Event Description

I have suffered irreversible tissue damage after being tricked into paying for a hazardous tattoo-removal product / procedure marketed and manufactured by the company rejuvatek medical, they're an embarrassment for your nation and they need to be stopped.The procedure is called tatt2away and involves an acid-like substance, terpsol, being injected into the skin through the use of various invasive instruments patented by this vicious company.The substance seem to consist mainly of lactic acid, which is described as a "severe skin and eye irritant" by the hhs (hsdb: lactic acid).When confronted, the company blames the customer and/or the specific clinic performing this harmful treatment.There are lots of warnings to be found on the internet, for example: federal institute for risk assessment (stellungnahme nr.033/2011); academic teaching hosp dresden-frieldrichstadt, dept of dermatology and allergology (wien med wochenschr - 2015 may); bispebjerg university hosp, dept of dermatology (skin res technol - 2018 nov); university of miami, dept of dermatology (dermato) surgery - 2008 nov); one of the company's employee, judy perkins, actively pretends to be a happy customer by leaving misleading comments on various youtube-videos.The following news-report shows a woman practicing the same harmful procedure through the news-team calls it "laser-removal" it is in fact the same kind of hazardous tatt2away-treatment (as seen at 1:10 and 1:45).Https://www.Youtube.Com/watch?v=jpo57eohyim.I've been in contact with multiple victims of this procedure, all of whom have been scarred for life.I've also got several medical certificates stating that this procedure is impossible to perform without seriously harming the pt (victim), all of which has been signed by medical drs / professionals from (b)(6).

• Brand Name: MASSIVE DELIVERY SYSTEM
• Type of Device: POWERE LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): REJUVATEK MEDICAL INC.
• MDR Report Key: 8760639
• MDR Text Key: 150408513
• Report Number: MW5087875
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: SE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 26 YR
• Patient Weight: 70