BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1416697 · Received May 14, 2009

    Report

    Report Number
    2032896-2009-00010
    Event Type
    Other
    Date Received
    May 14, 2009
    Date of Event
    May 5, 2009
    Report Date
    May 13, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA P020023. THE LOT NUMBER AND EXPIRATION DATE WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED RHINOPLASTY (DATE OF PROCEDURE NOT REPORTED). CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT RECEIVED A 0.2 TO 0.3 ML INJECTION OF RESTYLANE ON (B)(6) 2009 TO AN AREA OF THE LEFT NOSTRIL MEDIAL TO THE ALAR OF THE NOSE. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY PRE-PROCEDURE MEDICATIONS AND NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2009, ONE HOUR AFTER IMPLANTATION AND AFTER APPLYING ICE TO THE AREA AT HOME, THE PATIENT REPORTED THAT HER NOSE WAS TURNING BLUE; SHE NOTED THAT THIS HAPPENS WHEN IT IS "COLD OUT". THE PHYSICIAN SAW THE PATIENT AND OBSERVED THAT HER ENTIRE NOSE, THE AREA UP OVER THE GLABELLA, AND THE ENTIRE FRONTAL ASPECT BETWEEN THE BROWS WAS A MOTTLED COLOR; BLUENESS WAS NOTED IN THE SAME AREA. THE TIP OF HER NOSE WAS ALSO WHITE AND THEN RETURNED TO NORMAL COLOR (TIMEFRAME NOT REPORTED). THE PATIENT WAS TREATED WITH HYALURONIDASE AT 24 HOURS AND AGAIN AT 48 HOURS. THE PHYSICIAN BELIEVED THAT THE PRODUCT HAD CAUSED THESE SYMPTOMS.

    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 49 YR Other