BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 834586 · Received March 29, 2007

    Report

    Report Number
    9710154-2007-00005
    Event Type
    Other
    Date Received
    March 29, 2007
    Date of Event
    January 1, 2007
    Report Date
    March 20, 2007
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    p020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K)# P040024

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF A NON-SERIOUS, UNLABELED EVENT IS BEING SUBMITTED AS A 10-DAY REPORT. A FEMALE CONSUMER REPORTED THAT SHE RECEIVED INJECTIONS OF RESTYLANE INTO THE LIPS ON AN UNSPECIFIED DATE APPROXIMATELY IN 2007. IT IS UNKNOWN IF ANESTHESIA WAS ADMINISTERED PRE-PROCEDURE OR IF THE PATIENT UNDERWENT ADDITIONAL PROCEDURES AT THE TIME OR RESTYLANE TREATMENT. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE POST-RESTYLANE TREATMENT, THE PATIENT'S LIPS BEGAN TO PEEL "CONSTANTLY" (INJECTION SITE DESQUAMATION) AND BECAME "EXTREMELY" DRY (LIP DRY). SHE ALSO DEVELOPED DISCOLORATION OF THE LIPS (INJECTION SITE DISCOLORATION); THE NATURE OF THE DISCOLORATION WAS UNSPECIFIED. THE EVENT WAS ONGOING AS OF THE DATE THIS REPORT WAS RECEIVED. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 *