BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3250756 · Received July 19, 2013

    Report

    Report Number
    2032896-2013-00284
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    November 1, 2012
    Report Date
    July 3, 2013
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023/P040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT PAIN AND PERMANENT INDENTATION ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THE SPONTANEOUS CASE WAS REC'D ON (B)(6) 2013 FROM A CONSUMER AND CONCERNS A (B)(6) FEMALE PT. THE PT HAD NO RELEVANT MEDICAL HISTORY AND WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. ON (B)(6) 2012, THE PT REC'D THE RESTYLANE (HYALURONIC ACID) AND HAD PAIN AND WAS UNCOMFORTABLE AFTER THE INJECTION. THE BATCH NUMBER USED WAS REPORTED 11700. IN (B)(6) 2013 THE PT WAS SEEN BY DOCTORS AT THE OFFICE AND HAD A PERMANENT INDENTATION ON THE LEFT SIDE OF FACE AT THE NASAL LABIA FOLDS, IT WAS REPORTED THAT THE PT'S FACE LOOKED CAVED IN. IN V 2013 THE AREA ON THE FACE LOOKED FULLY INDENTED. THE RPTR STATED THAT PHOTOS WERE AVAILABLE TO SEND. NO ADD'L INFO WAS AVAILABLE AT THE TIME OF THE REPORT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338788 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED 11700

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other