BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE-L INJECTABLE GEL

    MDR report key: 2013090 · Received March 2, 2011

    Report

    Report Number
    2032896-2011-00006
    Event Type
    Other
    Date Received
    March 2, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 25, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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-L ((B)(4)). MEDICAL HISTORY INCLUDED A SULFA ALLERGY. THE PATIENT'S SKIN TYPE WAS FITZPATRICK 3. CONCOMITANT MEDICATIONS INCLUDED NEXIUM (ESOMEPRAZOLE MAGNESIUM) 40 MG ONCE DAILY. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE-L (AMOUNT INJECTED NOT REPORTED) FROM TWO 1.0 CC SYRINGES ON (B)(6) 2011, TO THE NASOLABIAL FOLDS. PRE-PROCEDURE MEDICATIONS INCLUDED TOPICAL BETACAINE. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2011 (ALSO REPORTED AS, "APPROXIMATELY (B)(6) WEEKS AFTER INJECTION"), THE PATIENT DEVELOPED A HARD, TENDER, RED NODULE AT THE SUPERIOR EDGE OF THE RIGHT NASOLABIAL FOLD. BACTERIAL CULTURES OF THE NODULE SITE PERFORMED ON (B)(6) 2011, WERE NEGATIVE. TREATMENT FOR THE REPORTED EVENT INCLUDED DOXYCYCLINE 200 MG DAILY; INJECTIONS OF KENALOG (TRIAMCINOLONE) 2.5 MG/ML INTO THE AFFECTED NODULE SEVEN TIMES ON UNSPECIFIED DATES BETWEEN (B)(6) 2011; AND INJECTIONS OF HYALURONIDASE INTO THE NODULE FOUR TIMES ON UNSPECIFIED DATES BETWEEN (B)(6) 2011. AS OF (B)(6) 2011, THE NODULE WAS STILL PRESENT AND TREATMENT WAS ONGOING. THE PHYSICIAN FELT THAT THE RESTYLANE-L TREATMENT CAUSED THE REPORTED EVENTS. THE PHYSICIAN ASSESSED THE SEVERITY OF THE REPORTED EVENTS AS SEVERE. THE LOT NUMBER AND EXPIRATION DATE FOR ONE OF THE RESTYLANE-L SYRINGES WAS 10632 AND NOV-2011, RESPECTIVELY. THE LOT NUMBER AND EXPIRATION DATE FOR THE OTHER RESTYLANE-L SYRINGE WAS 10384 AND MAY-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 60 YR Other| R PREV MEDS = NONE| NEXIUM (CON.) UNK