BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE CONTOUR

    MDR report key: 15066949 · Received July 19, 2022

    Report

    Report Number
    MW5110969
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    April 11, 2022
    Report Date
    July 17, 2022
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RESTYLANE DERMAL IMPROPERLY INJECTED BY MEDICAL PROFESSIONAL. ADVERSE EFFECTS: LUMPING AND IMPROPER PLACEMENT. RESTYLANE CONTOUR IMPROPERLY PLACED, HAVE HAD TO PAY OUT OF POCKET (B)(6) TO DISSOLVE SOME OF THE FILLER WITH HYALURONIDASE. LUMPING IS STILL PERSISTENT, UNABLE TO RESOLVE WITH IMAGE CENTER LOCATED IN HUNTINGTON BEACH. DURATION: 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252325 RESTYLANE CONTOUR IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other| R B-1 THIAMINE