BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1047452 · Received May 16, 2008

    Report

    Report Number
    9710154-2008-00008
    Event Type
    Other
    Date Received
    May 16, 2008
    Date of Event
    October 1, 2007
    Report Date
    May 13, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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 (TELANGIECTASIA) IS BEING SUBMITTED AS A 10 DAY REPORT. A HEALTH CARE PROVIDER REPORTED THAT A (B) (6) FEMALE PT RECEIVED INJECTIONS OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) INTO THE NASOLABIAL FOLDS ON AN UNSPECIFIED DATE IN (B) (6) 2007. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B) (6) 2007, THE PT EXPERIENCED A SMALL BROKEN BLOOD VESSEL ON THE LEFT NASOLABIAL FOLD THAT THE PHYSICIAN DIAGNOSED AS TELANGIECTASIS (TELANGIECTASIA). TREATMENT INCLUDED IPL (INTENSE PULSED LIGHT) LASER THAT WAS STARTED ON (B) (6) 2007. AS OF (B) (6) 2008, THE EVENT WAS RECOVERING. THE LOT NUMBER AND EXP 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 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR