BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2543170 · Received April 13, 2012

    Report

    Report Number
    2032896-2012-00011
    Event Type
    Other
    Date Received
    April 13, 2012
    Report Date
    April 5, 2012
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K): P040024.

    Description of Event or Problem · 1

    ON (B)(6), A SPONTANEOUS E-MAIL REPORT BY A PT TO A PHYSICIAN WAS RECEIVED VIA E-MAIL FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE (AGE NOT REPORTED), WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY, THE PT'S SKIN TYPE, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED AN INJECTION (VOLUME NOT REPORTED) OF RESTYLANE (SYRINGE SIZE NOT REPORTED) ON AN UNK DATE UNDER THE EYES. PRE-PROCEDURE MEDICATIONS AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNK DATE, AFTER THE IMPLANTATION, THE PT WENT BLIND. NO ADDITIONAL INFO WAS PROVIDED. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S PREV MEDS =UNKNOWN| CON MEDS =UNKNOWN