BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE SILK

    MDR report key: 6290027 · Received January 27, 2017

    Report

    Report Number
    MW5067555
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    December 3, 2016
    Report Date
    December 8, 2016
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS INJECTED IN MY UPPER LIP ON (B)(6) 2015. THE DAY AFTERWARDS, MY LIP SWELLED DRAMATICALLY. INITIALLY, IT WAS BELIEVED THAT THE INJECTOR HIT A BLOOD VESSEL WHICH CAUSED THE SWELLING. METHYLPREDNISONE TABLETS 4MG WERE PRESCRIBED THE FOLLOWING DAY POST INJECTION. THE FIRST WEEK OF (B)(6) 2016, I DEVELOPED A VAGINAL BACTERIAL INFECTION AND UNDERWENT TESTING TO CONFIRM PRIOR TO INITIATION OF ANTIBIOTICS. AS INFECTION PROGRESSED, ON (B)(6) 2016, I WOKE UP TO SEE THAT MY UPPER LIP WAS VERY SWOLLEN AGAIN SIMILAR TO WHEN I WAS FIRST INJECTED. I BELIEVE SOME SORT OF AUTOIMMUNE RESPONSE CAUSED ME TO HAVE THIS REACTION TO YOUR PRODUCT. I CONTACTED THE NURSE INJECTOR AT THE OFFICE- (B)(6) AT DR. (B)(6) OFFICE, AS WELL AS MY PRIMARY CARE PHYSICIAN DR. (B)(6), WHO WAS ALSO TREATING ME FOR MY UNDERLYING BACTERIAL INFECTION. NURSE (B)(6) PRESCRIBED ME METHYLPREDNISONE TABLETS 4MG ONCE AGAIN, AND THE SWELLING SUBSIDED AFTER TWO DAYS. I AM CONCERNED ABOUT RECURRENCE. PHOTOS INCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67529 RESTYLANE SILK RESTYLANE SILK LIP FILLER LMH GALDERMA LABORATORIES, L.P. 13553

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other METHYLPREDNISONE TABLETS 4MG