BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1422393 · Received July 24, 2009

    Report

    Report Number
    2032896-2009-00014
    Event Type
    Other
    Date Received
    July 24, 2009
    Date of Event
    June 1, 2009
    Report Date
    July 23, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. THE OTHER SUSPECT MEDICAL DEVICE IDENTIFIED IN THIS REPORT, PERLANE, HAS BEEN REPORTED AS MDR# 2032896-2009-00015 (B)(4). ADDITIONAL PMA# P020023.

    Description of Event or Problem · 1

    ON 07/14/2009, A SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) AND AN INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED PREVIOUS COSMETIC SURGERY INCLUDING A FACE LIFT, FACIAL PEEL, TUMMY TUCK, BREAST REDUCTION AND BREAST LIFT; THE PT HAD NO KNOWN MEDICAL CONDITIONS. CONCOMITANT MEDICATIONS INCLUDED ARMOUR THYROID (THYROID TABLETS, USP) FOR AN UNKNOWN DURATION. THE PT RECEIVED A 2 ML INJECTION OF RESTYLANE (2 SYRINGES) AND A 1 ML INJECTION OF PERLANE (1 SYRINGE) ON (B)(6) 2009 TO THE NASOLABIAL FOLD AND THE PREJOWL AREA. PRE-PROCEDURE MEDICATIONS INCLUDED UNSPECIFIED GENERAL ANESTHESIA. ADDITIONAL PROCEDURES AT THE TIME OF IMPLANTATION INCLUDED AN ARM LIFT AND A FACIAL PEEL. ON AN UNSPECIFIED DATE IN (B)(6) 2009, SOON AFTER THE PROCEDURE, THE PT EXPERIENCED AN INABILITY TO MOVE THE RIGHT SIDE OR HER FACE WELL. ON (B)(6) 2009, THE PT VISITED THE CLINIC FOR A SECOND OPINION. THE RESULT OF THE MEDICAL EVALUATION WAS MUSCLE WEAKNESS OR PARALYSIS TO THE RIGHT SIDE OF THE PT'S FACE. NO TREATMENT WAS PROVIDED. THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other ARMOUR THYROID (THYROID TABLETS, USP)| USP)