BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE L, RESTYLANE LIDOCAINE

    MDR report key: 3902266 · Received June 25, 2014

    Report

    Report Number
    2032896-2014-00424
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6)-2014 FROM A PHYSICIAN AND CONCERNS A (B)(6) FEMALE PATIENT. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6)-2014, THE PATIENT STARTED TREATMENT WITH RESTYLANE L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE) INJECTIONS, IN HER NASOLABIAL FOLDS (0.3 CC IN EACH FOLD), AND BROWS (0.2 CC IN EACH BROW) FOR DERMAL FILLING. THE PRODUCT LOT NUMBER WAS 11383. EXPIRATION DATE WAS LISTED AS 11/14. SOMETIME IN (B)(6) OF 2014, THE PATIENT DEVELOPED A HUGE GRANULOMA REACTION, BILATERALLY. THE GRANULOMA HAS BEEN TREATED WITH 5-FU (5-FLUOROURACIL) AND STEROID INFECTIONS (KENALOG), AND THUS THE GRANULOMA IS MUCH BETTER THAN BEFORE. IT WAS REPORTED THAT THE PATIENT HAS HAD RESTYLANE L AND JUVEDERM (CROSS-LINKED HYALURONIC ACID) BEFORE, WITH NO PROBLEM. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. FOR REFERENCE PURPOSES THIS CASE HAS BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370627 RESTYLANE L, RESTYLANE LIDOCAINE INJECTABLE DERMAL FILLER LMH Q-MED 11383

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other