BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACE FILLER

    MDR report key: 16844540 · Received April 28, 2023

    Report

    Report Number
    MW5117162
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    August 18, 2022
    Report Date
    April 23, 2023
    Manufacturer
    UNK
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM WRITING TO REPORT A SERIOUS ISSUE REGARDING THE USE OF FAKE FILLER DRUGS AND HAZARDOUS CHINESE DRUGS ON MY HEALTH AND FACE AT A MEDICAL SPA NAMED (B)(6). I BELIEVE THAT THIS ISSUE IS VERY SERIOUS AND NEEDS TO BE ADDRESSED IMMEDIATELY. ON (B)(6) 2022, I VISITED THIS MEDICAL SPA FOR THE TREATMENT OF MELASMA AND SKIN REJUVENATION BY MS. (B)(6) THE OWNER OF THE SPA AND THE ONE WHO ASKED ME TO DO ANTI-AGING WITH GOOD PRODUCTS MADE IN USA. I TRUST HER AT THAT TIME BUT WHEN SHE DIRECTLY INJECTED SOME SUBSTANCE LIKE SILICON INTO MY FACE WHEN I REQUESTED THE TREATMENT FOR PIGMENTATION AND ANTI-AGING WITH AHA AND COLLAGEN WITH HIGH QUALITY PRODUCTS NOT SILICON FILLER . UNLUCKY, THE FILLER SHE INJECTED, IT REMAINED HARD, PAINFUL, AND DISTORTED MY FACE. THE TISSUES ON BOTH CHEEKS WERE LOST AND SHRUNKEN, LOOKING VERY OLD AND BRUISED. IT WAS CLEAR THAT SHE USED LOW-QUALITY PRODUCTS FROM CHINA, WHICH I ACCIDENTALLY CAPTURED IN A PHOTO AT THE LAST TIME I WAS THERE! AFTER DISCOVERING THAT SHE USED LOW-QUALITY DRUGS, I STOPPED THE TREATMENT AND REFUSED TO PAY THE REMAINING AMOUNT OF THE (B)(6) SERVICE PACKAGE THAT I HAD PAID (B)(6) FOR IN ADVANCE. SHE BECAME ANGRY AND POSTED MY PICTURES ON A FACEBOOK GROUP, THREATENING AND DEFAMING MY REPUTATION IN PUBLIC WHILE SENDING ME VULGAR AND UNEDUCATED MESSAGES. AFTER THIS INCIDENT, I SUFFERED GREATLY, FEELING STRESSED AND BECOMING ILL FOR A MONTH DUE TO FATIGUE AND FEAR OF MY DISTORTED FACE. SHE INSULTED ME AND OTHER CUSTOMERS VERY BADLY THROUGH TEXT MESSAGES WHEN I REQUESTED HER TO PROVIDE THE NAME OF THE DRUG SHE HAD USED ON MY FACE. THE TREATING DERMATOLOGIST CANNOT TREAT ME WITHOUT MEDICAL RECORDS, WHICH SHE REFUSED TO PROVIDE BY WITHHOLDING THE NAME OF THE DRUG. THIS IS AN UNETHICAL, IRRESPONSIBLE, AND RISKY ACTION FOR CUSTOMERS' HEALTH. I THINK THAT USING FAKE AND SUBSTANDARD DRUGS IS A VERY SERIOUS ISSUE IN THE BEAUTY INDUSTRY AND NEEDS TO BE ADDRESSED SERIOUSLY AND COMPREHENSIVELY. OTHERWISE, (B)(6) WILL CONTINUE TO HARM MANY INNOCENT PEOPLE, LIKE ME, WHO LOSE BOTH MONEY AND HEALTH. AFTER BEING HARMED, I FOUND OUT THAT SHE HAS NO CREDENTIALS OR PROFESSIONAL CERTIFICATIONS, AND IS NOT AUTHORIZED TO INJECT DRUGS INTO CUSTOMERS' FACES, WHICH IS DANGEROUS TO THEIR HEALTH AND BEAUTY, AND CAN DISTORT THEIR FACES. I SINCERELY HOPE THAT THE FDA INVESTIGATIVE AGENCY WILL INTERVENE SOON TO RESTORE JUSTICE AND PROTECT THE HEALTH OF THE COMMUNITY. I THANK YOU SINCERELY AND LOOK FORWARD TO THE SUPPORT OF ALL CONCERNED AGENCIES IN THIS MATTER. BEST REGARDS(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534286 FACE FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention| S MULTI VITAMIN