FDA Adverse Event Injury Summary report: N

HYDROGEL

MDR report key: 10903784 · Received November 24, 2020

Report

Report Number
MW5098102
Event Type
Injury
Date Received
November 24, 2020
Date of Event
August 8, 2020
Report Date
November 20, 2020
Manufacturer
UNK
Product Code
PFP
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I GOT A NON SURGICAL PROCEDURE DONE BY A WOMAN NAME (B)(6) WHO HAS A MEDICAL SPA IN (B)(6). SHE WAS ADVERTISING AND OFFERING SCULPTRA INJECTIONS TO THE BUTTOCKS AREA FOR VOLUME AND MORE DEFINITION TO THE AREA. WHEN I GOT THERE SHE ASKED ME A SERIES OF COVID QUESTIONS AND EXPLAINED THE PROCEDURE AND EVALUATED MY BODY AND ASKED ME TO GO WASH MY HANDS. SHE THEN STERILIZED THE AREA AND BEGAN THE INJECTIONS THE AREA WAS A LITTLE SORE WHICH IS EXPECTED THE FIRST COUPLE DAYS. I HAD NO COMPLICATIONS UNTIL LATE SEPTEMBER I STARTED TO FEEL A SMALL SORE SPOT ON THE LOWER BUTTOCKS AREA, SO I REACH OUT TO HER SHE EXPLAINED THAT I NEED TO DO MASSAGE SO THE PRODUCT DOESN'T SETTLE IN ONE AREA WHICH SOUNDED A BIT STRANGE BECAUSE I REACH OUT TO A MEDICAL SPA IN MY AREA THEY NEVER EXPLAINED THAT TO ME. NOVEMBER 16 I REACHED OUT TO HER TO ASK HER WHAT CAN I DO BECAUSE THE LUMP HAS GOTTEN BIGGER AND IT'S KINDA UNCOMFORTABLE NOW AND WHY AM I HAVING THIS REACTION SHE TOLD ME TAKE ANTI INFLAMMATORY IBUPROFEN AND MASSAGE IT'S NORMAL. I LET MY FRIEND REACH OUT TO HER TO ACT LIKE A PAST CLIENT AND ACT LIKE SHE IS REFERRING SOMEONE TO HER BUT SHE ALREADY HAS ILLEGAL BUTT INJECTIONS WILL SHE BE A GOOD CANDIDATE FOR "SCULPTRA BUTT LIFT" (B)(6) SAID YES BECAUSE SHE USES THE PRODUCT "HYDROGEL" . I HAD NO IDEA THAT SHE INJECTED THIS DANGEROUS SUBSTANCE IN ME BECAUSE SHE IS ADVERTISING IT AS SCULPTRA INJECTIONS WHICH IS A POLYLACTIC ACID, WHICH WORKS BY INCREASING COLLAGEN PRODUCTION I SEEN NO RESULTS IN BUTTOCKS, SO I THOUGHT OK HUN WITH TIME AND MORE FOOD INTAKE I WOULD SEE RESULTS. NOW I HAVE THIS SUBSTANCE IN MY BODY THAT COULD BE VERY HARMFUL TO MYSELF AND THIS LADY IS DECEIVING PEOPLE ABOUT THE PRODUCTS THAT SHE IS INSERTING IN THE BODY. NO TEST YET . DOCTOR ASSESSED THE AREA TODAY. SCULPTRA BUTT LIFT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1354795 HYDROGEL SILICONE HYDROGEL FOR SCAR MANAGEMENT PFP UNK

Patients

Seq Age Sex Outcome Treatment
1 27 YR Life Threatening| O