BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 3092409 · Received April 30, 2013

    Report

    Report Number
    2032896-2013-00024
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA 9040024. VISUAL IMPAIRMENT IS SERIOUS, UNEXPECTED AND POSSIBLY RELATED. FACIAL PARALYSIS IS NON-SERIOUS, UNEXPECTED AND POSSIBLY RELATED, IMPLANT SITE MASS IS NON-SERIOUS, EXPECTED AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SPONTANEOUS REPORT WAS RECEIVED REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED WRINKLE TREATMENT. SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED AN INJECTION OF RESTYLANE (VOLUME INJECTED AND SYRINGE SIZE WERE NOT REPORTED ) SOMETIME TOWARDS THE END OF (B)(6) 2013. FOR WRINKLE TREATMENT. PRE-PROCEDURE MEDICATIONS AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. THE PT STATED THAT SHE WANTS TO COMPLAIN ABOUT THE NURSE WHO INJECTED HER IN HER NERVE NEAR HER EYES. THE PT SAID, "I HAVE HAD A PARALYSIS IN THE RIGHT SIDE OF FACE SINCE THE INJECTION. I HAVE PROBLEMS WITH MY VISION. MY RIGHT SIDE OF THE MOUTH IS NOW DROOPING SINCE IT IS DAMAGED. THE NURSE INJECTED RESTYLANE IN THE INTRA-ORBITAL NERVE." THE PT STATED THAT NOW SHE HAD DEVELOPED LUMPS UNDER THE EYE AREA AND ABOVE THE LIPS. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. FOR REF PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBER: (B)(4). (MEDCOMM SOLUTIONS ON BEHALF OF (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187564 RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| S