BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1865207 · Received October 5, 2010

    Report

    Report Number
    2032896-2010-00031
    Event Type
    Other
    Date Received
    October 5, 2010
    Report Date
    September 27, 2010
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA: P040024.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A LITERATURE REPORT FROM (B)(6) WAS RETRIEVED DESCRIBING A (B)(6) FEMALE WHO REC'D AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). NOH, SEONGMIN, ROH, MI RYUNG, LEE, SANG JU. RISK OF POSTINFLAMMATORY HYPERPIGMENTATION WITH FERN PATTERN TECHNIQUE IN INJECTING HYALURONIC ACID GEL. J. COSMET. DERMATOL. 2010 9 (3) :249-250. MEDICAL HISTORY INCLUDED A PROMINENT NASOLABIAL FOLD. THE PT'S SKIN TYPE WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNK DATE, THE PT REC'D AN INJECTION OF RESTYLANE (AMOUNT INJECTED NOT REPORTED) TO A PROMINENT NASOLABIAL FOLD. ON THE UPPER PART OF THE NASOLABIAL FOLD, BASIC LINEAR THREADING TECHNIQUES OF INTRADERMAL INJECTIONS WERE PERFORMED. FOR THE LOWER PART, NOVEL FERN PATTERN TECHNIQUE WAS PERFORMED, WHICH REQUIRED MULTIPLE INJECTIONS COMPARED TO THE BASIC LINEAR THREADING TECHNIQUE. PRE-PROCEDURE MEDICATIONS AND ADD'L PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNK DATE, AFTER THE IMPLANTATION, THE PT EXPERIENCED MILD ERYTHEMA AT THE UPPER PART OF THE NASOLABIAL FOLD AND PRURITUS AND ERYTHEMA AT THE LOWER PART OF THE NASOLABIAL FOLD. ON AN UNK DATE, TWO WEEKS AFTER THE IMPLANTATION, THE PT DEVELOPED POSTINFLAMMATORY HYPERPIGMENTATION (PIH) ON THE LOWER PART OF THE NASOLABIAL FOLD. ALTHOUGH, THE LINE ITSELF WAS CORRECTED, RESIDUAL PIH RESULTED IN A MORE VISIBLY APPARENT SHADOW-LIKE APPEARANCE IN THE LOWER PART BECAUSE OF THE PIGMENTATION, WHICH MADE THE PT DISSATISFIED. THE AUTHORS CONCLUDED THAT THE DERMATOLOGIST SHOULD BE AWARE THAT ALTHOUGH THIS TECHNIQUE IS VERY SATISFACTORY IN CORRECTING DYNAMIC FACIAL LINE, IT COULD RESULT IN PIH THAT MAY AGGRAVATE THE APPEARANCE OF THE FOLDS. NO ADD'L INFO WAS PROVIDED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR PREV MEDS =UNKNOWN| CON MEDS =UNKNOWN