BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE

    MDR report key: 3022859 · Received March 21, 2013

    Report

    Report Number
    MW5029499
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BIOFORM MEDICAL, INC
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HAD RADIESSE FILLER PUT IN ON (B)(6) 2013, FROM THAT POINT ON IT WAS A NIGHTMARE!!!!!! I AM TERRIFIED! THE FOLLOWING DAY I HAD NUMBNESS WHICH DR SAID IS "NORMAL", SO I BELIEVED HER. EVER SINCE THEN, I HAVE NUMBNESS ON THE LEFT SIDE OF FACE, HANDS ARE RED SWOLLEN AND ACHE, ALL MUSCLES ARE WEAK AND ACHY, HEADACHES, SLEEPLESSNESS. MY WHOLE BODY IS WEAK. SINCE ALL OF THIS I HAVE DONE RESEARCH ON REVIEWS AND I HAVE PAGES OF PEOPLE WHO HAVE EXPERIENCED THE SAME EXACT THING I AM GOING THROUGH. I AM SOOOO SCARED. I DON'T WANT TO BE LIKE THIS THE REST OF MY LIFE. I HAD TO GO TO THE ER (B)(6) 2013. BEEN TO FAMILY DR (B)(6) SEVERAL TIMES. I AM HOPING I CAN GET HELP AND ANSWERS. THIS PRODUCT SHOULD NOT BE ON THE MARKET!!!!!!!!! PLEASE GET BACK TO ME AS SOON AS POSSIBLE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117996 RADIESSE RADIESSE LMH BIOFORM MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O