BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TATT2AWAY "HANDPIECE"

    MDR report key: 19342968 · Received May 16, 2024

    Report

    Report Number
    MW5155074
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    May 1, 2023
    Report Date
    May 14, 2024
    Manufacturer
    REJUVATEK MEDICAL, INC.
    Product Code
    GFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM WRITING YOUR OFFICE TO REPORT SEVERAL DISFIGURATIONS BY TATT2AWAY TATTOO REMOVAL USING A MACHINE THAT PUMPS A CLEAR SOLUTION UNDER THE SKIN WITH THE INTENT OF THE TATTOO FALLING OFF AS A SCAB. THIS BUSINESS IS A THREAT TO PUBLIC SAFETY AND HAS HARMED MANY PEOPLE. AFTER A SEVERE REACTION TO THIS PROCEDURE, THE COMPANY WOULD NOT DISCLOSE WHAT WAS IN THE CLEAR SOLUTION, NAMED TEPRSOL AS THEY STATED IT WAS "PATENTED" AND CONFIDENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616029 TATT2AWAY "HANDPIECE" BRUSH, DERMABRASION, POWERED GFE REJUVATEK MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H