BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2261695 · Received September 21, 2011

    Report

    Report Number
    2032896-2011-00057
    Event Type
    Other
    Date Received
    September 21, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 13, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K #: P040024.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE (AGE NOT REPORTED) WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY, THE PATIENT'S SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE (SYRINGE SIZE AND AMOUNT INJECTED NOT REPORTED) ON AN UNSPECIFIED DATE IN (B)(6) 2011 (REPORTED AS "3 WEEKS AGO" FROM THE DATE OF THE REPORT) TO THE NASOJUGAL FOLD. PER-PROCEDURE MEDICATIONS USED AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2011, AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED LYMPHATIC SWELLING. TREATMENT INCLUDED AN INJECTION OF HYALURONIDASE ON AN UNSPECIFIED DATE IN (B)(6) 2011, WHICH DID NOT RESOLVE THE ISSUE. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN