MAUDE Adverse Event Report: UNKNOWN LIP FILLERS; ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Undesired Nerve Stimulation (1980); Cramp(s) /Muscle Spasm(s) (4521); Subcutaneous Nodule (4548)

Event Date 09/07/2022

Event Type  Injury  

Event Description

I got fraudulent lip fillers injected into my lips and she turned her hand quick and injected the rest of the lip fillers in between my eyebrows.She never stated name of the filler, prescription number, i never signed any paperwork, the cost was only (b)(6)now i'm worried for my long term health.I have bumps inside my lips and quick twitches and random weird feelings in between my eyebrows a year later.This is the story i submitted to the fda: my name is (b)(6).I went to (b)(6) on (b)(6) 2022.On this day, i was injected with illegal lip filler by a woman pretending to be a nurse her name is (b)(6), she is the owner of the (b)(6) offered at two locations: (b)(6).She tells everyone she's a nurse and posted so online and, on her instagram, but when i called the health inspector and board of nursing in (b)(6), they said she doesn't exist in their system! now that i check her website the title " nurse " has been removed but i have screenshots of everything.Today, on her website, she writes " she received a degree in anatomy from (b)(6) and specialized in advanced cosmetic procedures licensed by the (b)(6) is literally spelt wrong and neither qualify her to inject into the skin and blood vessels.She recommended a lower price lip filler for (b)(6) which usually costs (b)(6).I should have run at that first red flag but i trusted that she was a nurse.She used contaminated gloves and injected me with an illegal substance in my lips and proceeded to use the same needle to inject the rest of the product in between my eyebrows, the same lip filler needle which i didn't consent to.I signed no paperwork, and she didn't even tell me the name of what filler it was!!! i called to ask for the prescription number she says it doesn't come with one and that she bought the product from china and brazil.To this day i have lumpy lips and tingling in between my eyebrows.Highly illegal.Normally, injectable hyaluronic acid fillers come with prescription numbers because they are medical substances and can only be injected under a doctor or np so she 100% ordered counterfeit cheaper products and is not certified to inject needles into people.When i asked her about this she said she'd look for the prescription number for me but she "threw it away already".To this day i don't know if the needle was clean or what i was injected with and that is terrifying.It's hard to find on her website (b)(6) but pictures are posted on their instagram (b)(6).This is seriously a dangerous crime happening right in front of everyone and she's getting away with it.People can be blinded or die!! please go in and request fillers/or botox and see for yourself.There are other reports of this on google as well from other victims.She also micro-bladed my brows and used dirty gloves after touching her phone and was on a phone call tapping her phone with the same gloves while cutting into my facial skin.This is highly invasive just like the injectables, i bled so much and did some research after that estheticians cannot break the skin epidermis deep enough to cause bleeding, never mind inject foreign substances.I am desperately asking you please use your better resources to investigate this.I'm a college educated 22-year-old at (b)(6) i know this is wrong and illegal.If more information is needed, please let me know i have receipts of everything.I have not seen a doctor but i know i am suffering from the effects of this with whatever substance she injected inside me.Reference report: mw5149336.

• Brand Name: LIP FILLERS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18356484
• MDR Text Key: 330974874
• Report Number: MW5149335
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White