BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE L, RESTYLANE LIDOCAINE

    MDR report key: 3170075 · Received June 5, 2013

    Report

    Report Number
    2032896-2013-00149
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    Q-MED
    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

    PHARMACOVIGILANCE COMMENT: (B)(4) 2013. GLABELAR NECROSIS ASSESSED AS SERIOUS, EXPECTED AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN AND CONCERNS (B)(6) FEMALE PATIENT. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE PT STARTED TREATMENT WITH RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE) FOR AN UNK INDICATION. LOT NUMBER: 12039. EXP DATE: 09/2015. ON (B)(6) 2013, THE PT'S EXPERIENCED A GLABELLAR NECROSIS REACTION. THE OUTCOME OF THE EVENT WAS UNK. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249523 RESTYLANE L, RESTYLANE LIDOCAINE INJECTABLE DERMAL FILLER LMH Q-MED 12039

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR