BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE L, RESTYLANE LIDOCAINE

    MDR report key: 3142894 · Received May 29, 2013

    Report

    Report Number
    2032896-2013-00126
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 14, 2013
    Manufacturer
    Q- MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2013 FROM A SALES REP VIA AN OFFICE MANAGER AND CONCERNS AN UNK FEMALE PT. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNK DATE, THE PT STARTED TREATMENT WITH RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE) FOR AN UNK INDICATION. THE BATCH NUMBER USED WAS NOT REPORTED. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED EXTREME, SEVERE SWELLING OF THE FACE: FROM THE CHEEKS TO THE LOWER EYELIDS, TO THE TEAR TROUGHS, AND FROM THE NASAL LABIAL FOLDS TO THE LIP AREA. ON (B)(6) 2013, MEDICAL INFO CONTACTED THE PHYSICIAN'S OFFICE FOR FURTHER INFO, BUT THERE WAS NO ANSWER. THE OUTCOME OF THE EVENT WAS UNK. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4) ((B)(4) ON BEHALF OF VALEANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233905 RESTYLANE L, RESTYLANE LIDOCAINE INJECTABLE DERMAL FILTER LMH Q- MED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other