BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 3143163 · Received May 24, 2013

    Report

    Report Number
    2032896-2013-00056
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 22, 2013
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT AS RECEIVED BY VALEANT. CASE DESCRIPTION: THIS SPONTANEOUS REPORT REFERS TO A FEMALE PATIENT WITH AN UNKNOWN CONDITION. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH RESTYLANE, FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PARALYSIS IN LIPS, LEFT SIDE OF MOUTH. THE OUTCOME OF THE EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE. FOR REFERENCE PURPOSE ONLY, THE FOLLOWING TRACKING NUMBER HAS BEEN ASSIGNED: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232596 RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED 12039-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other