BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 834595 · Received March 29, 2007

    Report

    Report Number
    9710154-2007-00006
    Event Type
    Other
    Date Received
    March 29, 2007
    Date of Event
    February 11, 2006
    Report Date
    March 22, 2007
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    p020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 (TELANGIECTASIA) IS BEING SUBMITTED AS A 10-DAY REPORT. INFORMATION WAS RECEIVED REGARDING A FEMALE WHO RECEIVED 4-5 INJECTIONS OF RESTYLANE INTO EACH NASOLOBIAL FOLD RIM IN 2006. AN UNSPECIFIED "NUMBING AGENT" WAS ADMINISTERED AS AN ANESTHETIC PRE-PROCEDURE. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF RESTYLANE TREATMENT. THE PATIENT HAD NO SIGNIFICANT MEDICAL HISTORY AND WAS NOT TAKING CONCOMITANT MEDICATIONS. IN 2006, THE PATIENT DEVELOPED "REDNESS AND SHADOWS", "LIKE CAPILLARIES", AT THE INJECTION SITES. ADDITIONALLY, THE PATIENT REPORTEDLY COULD FEEL THE PRODUCT BENEATH HER SKIN (MEDICAL DEVICE IMPLANTATION). THE PATIENT WAS EXAMINED BY A PHYSICIAN, WHO DESCRIBED A RIM OF CREST-SHAPED ERYTHMA," WHICH WAS DIAGNOSED AS TELANGIECTASIA (TELANGIECTASIA). AS OF THE DATE THIS REPORT WAS RECEIVED, THE EVENT HAD ABATED, BUT WAS NOT COMPLETELY RESOLVED. 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 LNM Q-MED AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR