BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 843010 · Received April 20, 2007

    Report

    Report Number
    9710154-2007-00007
    Event Type
    Other
    Date Received
    April 20, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 13, 2007
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    p020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K): P040024.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF A NON-SERIOUS, UNLABELED EVENT (LIP DRY) IS BEING SUBMITTED AS A 10-DAY REPORT. A HEALTHCARE PROVIDER REPORTED THAT A FEMALE PATIENT RECEIVED INJECTIONS OF RESTYLANE INTO THE GLABELLA, SIDES OF MOUTH, AND LOWER LIP IN 2007. NO ANESTHESIA WAS ADMINISTERED PRE-PROCEDURE, AND NO ADDITIONAL PROCEDURES WERE PERFORMED. THE PATIENT HAD NO SIGNIFICANT MEDICAL HISTORY AND WAS NOT TAKING CONCOMITANT MEDICATIONS. ON AN UNSPECIFIED DATE POST-RESTYLANE TREATMENT, THE PATIENT DEVELOPED DRYNESS OF HER LOWER LIP (LIP DRY), WHICH LASTED " A FEW DAYS." THE PATIENT SELF-TREATED HER DRY LIP WITH VASELINE (PETROLEUM JELLY), AND THE DRYNESS RESOLVED. THE FOLLOWING MONTH, THE PATIENT REPORTED TO THE HEALTH CARE PROVIDER THAT THE PRODUCT SEEMED "TO BE GONE" (DEVICE INEFFECTIVE). NINE DAYS LATER, THE PT WAS EXAMINED BY THE HEALTH CARE PROVIDER, WHO NOTED THAT THE PRODUCT HAS DISSIPATED. THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS 8036 AND 05/2009, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LNM Q-MED AB NA 8036

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR