BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3082873 · Received April 1, 2013

    Report

    Report Number
    2032896-2013-01751
    Event Type
    Injury
    Date Received
    April 1, 2013
    Report Date
    March 15, 2013
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN, REGARDING A FEMALE PT WHO RECEIVED AN INJECTION OF HALF SIZE RESTYLANE. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNK DATE, FOLLOWING TREATMENT WITH RESTYLANE, THE PT EXPERIENCED PURPLE/BLACK ATROPHIC AREA OF HER LEFT CHEEK. THIS REQUIRED 3CCS OF JUVEDERM TO FILL THE HOLE. NO ADDITIONAL INFO WAS PROVIDED. F/U INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131525 RESTYLANE, RESTYLANE NONE LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention