BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2020370 · Received March 10, 2011

    Report

    Report Number
    2032896-2011-00009
    Event Type
    Other
    Date Received
    March 10, 2011
    Report Date
    February 28, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K): P040024.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A LITERATURE REPORT FROM (B)(6) WAS RETRIEVED DESCRIBING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). SHAFIR R, AMIR A, GUR E. LONG-TERM COMPLICATIONS OF FACIAL INJECTIONS WITH RESTYLANE (INJECTABLE HYALURONIC ACID). PLAST RECONSTR SURGERY 2000;106 (5):1215-6. MEDICAL HISTORY, SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED SEVERAL INJECTIONS OF RESTYLANE (AMOUNT INJECTED NOT REPORTED) ON AN UNKNOWN DATE (REPORTED AS "2 MONTHS EARLIER" FROM THE DATE OF THE LITERATURE REPORT) TO THE LIPS AND NASOLABIAL FOLDS. THE INJECTION WAS PERFORMED BY A CERTIFIED PLASTIC SURGEON. PRE-PROCEDURE MEDICATIONS USED AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNKNOWN DATE, 2 MONTHS AFTER THE INJECTIONS, LOCALIZED SWELLINGS THAT LOOKED LIKE WHITE ABSCESSES APPEARED AT THE INJECTION SITES, THE UPPER AND LOWER LIPS, AND THE NASOLABIAL FOLDS. TWO OF THE SWELLINGS RUPTURED SPONTANEOUSLY, AND THE TREATING PHYSICIANS INCISED THE OTHERS (TO PREVENT RUPTURE) AND DRAINED THEM OVER A PERIOD OF SEVERAL WEEKS. THE DRAINED MATERIAL HAD A PUSLIKE APPEARANCE, BUT THE CULTURE RESULTS WERE NEGATIVE SO THE TREATING PHYSICIANS INJECTED SOME OF THE LATER SWELLINGS WITH UNSPECIFIED STEROIDS SHORTLY AFTER THEY EMERGED. AT THE TIME OF THE ARTICLE'S PUBLICATION, THE PATIENT WAS STILL UNDERGOING TREATMENT.

    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 36 YR Other| R CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN