BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE-L INJECTABLE GEL

    MDR report key: 2040209 · Received March 25, 2011

    Report

    Report Number
    2032896-2011-00014
    Event Type
    Other
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 17, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, A SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE-LY (CROSS-LINKED HYALURONIC ACID DERMAL FILLED WITH 0.3% LIDOCAINE). MEDICAL HISTORY WAS NEGATIVE WITH NO PREVIOUS AESTHETIC PROCEDURES. THE PT'S SKIN TYPE WAS FITZPATRICK III. THE PT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PT RECEIVED A 2 CC INJECTION OF RESTYLANE-L ON (B)(6) 2011 TO THE MARIONETTE LINES. NO PRE-PROCEDURE MEDICATIONS WERE USED AND NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON AN UNSPECIFIED DATE IN (B)(6) 2011, 3-4 DAYS AFTER THE INJECTION, THE PT NOTICED SIGNIFICANT SWELLING OF THE LEFT ANTERIOR CERVICAL LYMPH NODE (4 CM) WITH TENDERNESS AND NO FEVER. THE PT HAD MILD SWELLING OF THE RIGHT LYMPH NODE (2 CM). AS OF (B)(6) 2011, 12 DAYS POST-PROCEDURE, THE PT'S LEFT LYMPH NODE WAS 1.5 CM AND THE RIGHT LYMPH NODE SWELLING WAS RESOLVED. THE RESULT OF THE PHYSICIAN'S MEDICAL EVALUATION WAS LYMPHATIC BLOCKAGE. NO TREATMENT WAS PROVIDED. THE PHYSICIAN FELT IT WAS POSSIBLE THE TREATMENT WITH RESTYLANE-L CAUSED THE REPORTED EVENTS. THE PHYSICIAN ASSESSED THE SEVERITY OF THE REPORTED EVENTS AS COSMETICALLY SEVERE AND MEDICALLY MODERATE. THE LOT NUMBER AND EXPIRATION DATE WERE 10632 AND 11/2011, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE-L INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB 10632

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR CON MEDS =NONE| PREV MEDS =NONE