FDA Adverse Event Injury Summary report: N

MASSIVE DELIVERY SYSTEM

MDR report key: 8760639 · Received July 2, 2019

Report

Report Number
MW5087875
Event Type
Injury
Date Received
July 2, 2019
Date of Event
October 25, 2017
Report Date
June 30, 2019
Manufacturer
REJUVATEK MEDICAL INC.
Product Code
GEX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
SE
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
546073 MASSIVE DELIVERY SYSTEM POWERE LASER SURGICAL INSTRUMENT GEX REJUVATEK MEDICAL INC.

Patients

Seq Age Sex Outcome Treatment
1 26 YR Life Threatening| O