BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 920827 · Received September 28, 2007

    Report

    Report Number
    9710154-2007-00019
    Event Type
    Other
    Date Received
    September 28, 2007
    Date of Event
    January 1, 2007
    Report Date
    September 19, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)# P040024. (SEE SCANNED PAGES).

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF A NON-SERIOUS, UNLABELED EVENT (POST-INFLAMMATORY HYPERPIGMENTATION) IS BEING SUBMITTED AS A 10-DAY REPORT. INFORMATION WAS RECEIVED FROM A FEMALE CONSUMER WHO RECEIVED INJECTIONS OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) INTO THE NASOLABIAL FOLDS AND INTO THE AREAS EXTENDING FROM THE ORAL COMMISSURES TO THE CHIN BILATERALLY IN 2007. MEDICAL HISTORY INCLUDED HYPERTENSION AND 5 OR 6 PREVIOUS RESTYLANE TREATMENTS WITHOUT INCIDENT. CONCOMITANT MEDICATIONS INCLUDED LISINOPRIL 5-10 MG DAILY "FOR YEARS," WELLBUTRIN (BUPROPION HCL) 150 MG DAILY, UNSPECIFIED MULTIVITAMINS, VITAMIN C, AND AN UNSPECIFIED CALCIUM SUPPLEMENT. ON AN UNSPECIFIED DATE POST-RESTYLANE TREATMENT, THE PATIENT REPORTEDLY DEVELOPED BILATERAL "BLUE DISCOLORATION IN A LINE, WHERE THE RESTYLANE WAS INJECTED" FROM HER MOUTH TO HER CHIN, WHICH SHE DESCRIBED AS LOOKING "LIKE A BRUISE UNDER THE SKIN" AND "LIKE A MUSTACHE." ON AN UNSPECIFIED DATE, THE PATIENT WAS EXAMINED BY THE INJECTING PHYSICIAN. ACCORDING TO THE PHYSICIAN, NO BRUISING WAS OBSERVED IN THE INJECTED AREAS. THE PHYSICIAN DESCRIBED POSSIBLE SUPERFICIAL IMPLANT (DEVICE EXTRUSION) AND AN AREA OF DISCOLORATION THAT WAS NOT BLUE BUT WAS "DARK" IN COLOR. THE PHYSICIAN SUSPECTED POST-INFLAMMATORY HYPERPIGMENTATION (POST INFLAMMATORY PIGMENTATION CHANGE). AS OF 09/19/2007, THE EVENT WAS ONGOING. THE RESTYLANE 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 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR VITAMIN C| UNSPECIFIED CALCIUM SUPPLEMENT| WELLBUTRIN (BUPROPION HCL) 150 MG DAILY| UNSPECIFIED MULTIVITAMINS| LISINOPRIL 5-10 MG DAILY "FOR YEARS"