BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANOFI-AVENTIS

    MDR report key: 2021681 · Received March 13, 2011

    Report

    Report Number
    MW5019789
    Event Type
    Injury
    Date Received
    March 13, 2011
    Date of Event
    January 16, 2010
    Report Date
    March 13, 2011
    Manufacturer
    SANOFI-AVENTIS U.S.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    SECOND ADMINISTRATION OF SCULPTRA AESTHETIC -PMA NO P030050, MFR SANOFI-AVENTIS U.S. LLC- IN THE REGION OF THE NASOLABIAL FOLDS CAUSED RAPIDLY PROGRESSIVE TOXIC MYOPATHY LEADING TO SEVERE BULBAR AND UPPER LIMB PREDOMINANT WEAKNESS, PARTIAL PARALYSIS OF THE MUSCLES OF THE FACE, PROFOUND WEAKNESS OF THE MUSCLES OF THE FACE, PROFOUND WEAKNESS OF THE MUSCLES OF THE TONGUE, ARMS, AND HANDS. SYMPTOMS INCLUDE DYSPHAGIA, DEVELOPMENT OF CANDIDIASIS, ASPIRATION PNEUMONIA, BILATERAL PAINFUL FOREARMS, POSTURING OF THE HANDS IN A CLAW-TYPE MANNER, DYSARTHRIA, FACIAL DISFIGUREMENT INCLUDING PTOSIS AND FACIAL DROOP, GENERAL MALAISE, RAPIDLY PROGRESSIVE WEAKNESS, MARKED ATROPHY OF BILATERAL FOREARMS, PREDOMINANTLY IN THE DISTAL DORSAL FOREARM, MARKED WASTING OF THE SMALL MUSCLES OF THE HANDS, AND SEVERE PROXIMAL AND MILD DISTAL WEAKNESS OF THE LOWER LIMBS. AFTER MONTHS OF DIAGNOSTIC TESTS AND EXAMINATION, THE PT HAS BEEN DIAGNOSED WITH INFLAMMATORY MYOPATHY COMBINED WITH MYASTHENIA GRAVIS. THE PT'S CONDITION HAS REQUIRED MULTIPLE HOSPITALIZATIONS AND IS SOMEWHAT ALLEVIATED BY STEADY ADMINISTRATION OF CORTICOSTEROIDS RESULTING IN MOON FACE, HAIR LOSS, EASY BRUISING AND THIN SKIN. THE PT REMAINS DISABLED AND SIGNIFICANTLY IMPAIRED IN THE ACTIVITIES OF DAILY LIVING. SCULPTRA AESTHETIC, ADMINISTERED IN (B)(6) 2009 AND (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANOFI-AVENTIS SCULPTRA AESTHETIC LMH SANOFI-AVENTIS U.S. NOT KNOWN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R