BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA, POLY-L-LACTIC ACID

    MDR report key: 3963941 · Received July 14, 2014

    Report

    Report Number
    3009443653-2014-00160
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    February 6, 2014
    Manufacturer
    VALEANT PHARMACUETICALS NORTH AMERICA LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: (B)(6) 2014 RASH, NODULE, HYPERKERATOSIS, ACANTHOSIS, FIBROSIS, ANGIOFIBROMA, NEURODERMATITIS, ACANTHOMA, SKIN ULCER, SWELLING FACE, DERMATITIS HERPETIFORMIS, SOCIAL AVOIDANT BEHAVIOUR, IMPAIRED WORK ABILITY, SOCIAL PROBLEM, ORAL HERPES ASSESSED AS SERIOUS AND POSSIBLY RELATED. HOWEVER, THE PATIENT HAD SEVERAL OTHER UNDERLYING MEDICAL CONDITION AND WAS ON OTHER PRODUCTS WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THE EVENTS. (B)(6) 2014 NO CHANGE TO PREVIOUS MEDICAL ASSESSMENT. (B)(6) 2014 EVENT OF EAR PAIN, INSOMNIA, UPPER RESPIRATORY TRACT INFECTION, ARTHRALGIA, IMPETIGO, CERUMEN IMPACTION, HEAD TRAUMA, CONJUNCTIVAL HAEMORRHAGE ASSESSED AS NON SERIOUS AND UNLIKELY RELATED. LONG LAG BETWEEN THE ONSET OF THESE EVENTS AND THE PRODUCT USE END DATE. NO CHANGE TO PREVIOUS MEDICAL ASSESSMENT. (B)(6) 2014 EVENTS OF MADAROSIS, APPLICATION SITE EROSION ASSESSED AS SERIOUS AND POSSIBLY RELATED. NO CHANGE TO PREVIOUS MEDICAL ASSESSMENT. (B)(6) 2014 EVENT OF DYSPEPSIA ADDED AND ASSESSED AS NON SERIOUS AND POSSIBLY RELATED. NO CHANGE TO PREVIOUS MEDICAL ASSESSMENT. (B)(6) 2014 NO CHANGE TO PREVIOUS MEDICAL ASSESSMENT.

    Description of Event or Problem · 1

    THIS CASE WAS RECEIVED BY VALEANT FROM SANOFI-AVENTIS VIA MEDICAL RECORDS: THIS CASE CONCERNED A (B)(6) PATIENT (CURRENT AGE) . THE PATIENT'S MEDICAL HISTORY INCLUDED PHOTOSENSITIVE/PHOTO ALLERGIC, MARFATKED SUN EXPOSURE OVER THE YEARS, KNEE REBUILD IN 1983, POOR DIET, LACK OF EXERCISE, STRESS, SKIN MASS, SCABS, URINARY TRACT INFECTION, SKIN COSMETIC PROCEDURE, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, TOBACCO USER, RECREATIONAL DRUG USE, ALCOHOL USE, CHICKENPOX, DEPRESSION, ANXIETY, PREVIOUS PREGNANCY, HEART MURMUR, MIGRAINE, ARTHRITIS, ASTHMA, THYROID DISEASE. THE PATIENT HAD A FAMILY HISTORY OF MELANOMA, HEARING LOSS, HIGH BLOOD PRESSURE AND KIDNEY DISEASE. CONCOMITANT MEDICATIONS INCLUDED DEXEDRINE (DEXTROAMPHETAMINE) FOR ADD (ATTENTION DEFICIT/HYPERACTIVITY DISORDER), LEXAPRO (ESCITALOPRAM). ON (B)(6) 2007 THE PATIENT WAS ADMINISTERED WITH SCULPTRA (INJECTABLE POLY-1-LO.CTIC ACID) TO VOLUMIZE THE CHEEKS. CO-SUSPECT MEDICATION INCLUDED BOTOX (ONABOTULINUMTOXINA), JUVEDERM (CROSS LINKED HYALURONIC ACID) ON (B)(6) 2009 THE PATIENT WAS INJECTED WITH BOTOX IN THE OUTER EYEBROWS, PROCERUS, GLABELLA, AND CORRUGATOR MUSCLES. ON AN UNKNOWN DATE THE PATIENT WAS ADMINISTERED WITH JUVEDERM. IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE FRAXEL LASER RESURFACING TREATMENT ON (B)(6) 2007, (B)(6) 2008, AND (B)(6) 2009. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED DEEP BREAKOUT/ERUPTIONS, ITCHY/INFLAMED/PAINFUL BUMPS, HYPERKERATOSIS, EPIDERMAL ACANTHOSIS, UNDERLYING FIBROSIS AND FIBROMA, PRURIGO NODULARIS, SQUAMOUS ACANTHOMA, ULCERATED AREA BETWEEN EYEBROWS BY THE NOSE, SWOLLEN EYEBROW AREA/CHEEKS/NOSE/CHIN, DERMATITIS HERPETIFORMIS, LOSS OF AUTHORITY IN THE CLASS ROOM AND PROFESSIONAL STANDING AT COLLEGE, LOSS OF SOCIAL CONFIDENCE, BECOMING A RECLUSE AND AVOIDING SOCIAL CONTACT, BEING TREATED POORLY IN PUBLIC SETTINGS. TREATMENT FOR ADVERSE EVENTS INCLUDED DORYX (DOXYCYCLINE), VALTREX (VALACICLOVIR), PREDNISONE, CELIDIN, DIFFERIN (ADAPALENE), E-LIGHT SKIN TREATMENT. IT WAS REPORTED THAT THE PATIENT CONTINUED TO WORK FULL TIME THOUGH THE 2010/2011 ACADEMIC YEAR AT WHICH TIME SHE REDUCED HER WORKLOAD BY 60%, AFTER WHICH SHE STOPPED WORKING AND RETIRED EARLY. SKIN BIOPSY WAS PERFORMED ON (B)(6) 2011 ON RIGHT ELBOW WITH RESULT SHOWING EXCORIATION. AEROBIC BACTERIAL CULTURE FOR ON (B)(6) 2010 SHOWED NO GROWTH. BLOOD PRESSURE READING ON (B)(6) 2011 WAS 122/73; PULSE RATE WAS 85. THE OUTCOME OF THE EVENTS WERE REPORTED TO BE NOT RECOVERED AND PERMANENT. FOLLOW UP INFORMATION RECEIVED VIA MEDICAL RECORDS ON (B)(6) 2014: ON AN UNKNOWN DATE, A LEFT CALF BIOPSY WAS PERFORMED. THE RESULTS SHOWED EPIDERMAL ACANTHOSIS WITH FOCAL DERMAL FIBROPLASIA. FOLLOW UP INFORMATION RECEIVED VIA MEDICAL RECORDS ON (B)(6) 2014: EVENT OF EAR PAIN, CERUMEN IMPACTION, INSOMNIA, UPPER RESPIRATORY TRACT INFECTION, ARTHRALGIA, HEAD TRAUMA, CONJUNCTIVAL HAEMORRHAGE ADDED. IMPETIGO, MEDICAL HISTORY OF THYROMEGALY, ACNE, SCIATICA ADDED. EKG ADDED TO LAB SECTION. CONCOMITANT MEDICATIONS CIPROFLOXACIN/HYDROCORTISONE, NABUMETONE, THYROID, DOXYCYCLINE HYCLATE, DEXTROAMPHETAMINE SULFATE ADDED. FOLLOW UP INFORMATION RECEIVED VIA MEDICAL RECORDS ON (B)(6) 2014: EVENTS ADDED OF FACE: LOSS OF EYEBROWS, EXCORIATED SKIN, LEFT WORSE THAN RIGHT, SOME CRUSTION, OTHER PATCHY ERYTHEMATOUS LESIONS RIGHT NL FOLD. EXAM INFORMATION ADDED (B)(6) 2013 PROCEDURES: OPEN BIOPSY WAS PERFORMED UNDER LOCAL/STERILE CONDITIONS WITH PATIENT CONSENT LEFT EYEBROW SPECIMEN REMOVED WAS SENT FOR PATHOLOGICAL EXAMINATION AND IMMUNO. MICROSCOPIC EXAM: FLUORESCEIN LABELED ANTIBODIES TO HURNEN IGG, IGM, IGA, C3 AND FIBRINOGEN WERE USED. THERE WERE NO SIGNIFICANT IMMUNE DEPOSITS DETECTED. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 VIA MEDICAL RECORDS: EVENT OF INDIGESTION ADDED. FATIGUE, CARPAL TUNNEL SYNDROME ADDED TO MEDICAL HISTORY. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 VIA LABORATORY RECORDS: NO NEW INFORMATION. THIS CASE WAS RECEIVED BY SANOFI-AVENTIS AND WAS FORWARDED TO VALEANT ON (B)(6) 2013. FOLLOW UP INFORMATION WAS FORWARDED TO VALEANT ON (B)(6) 2014. FOLLOW UP INFORMATION WAS FORWARDED TO VALEANT ON (B)(6) 2014. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2014 AND FORWARDED TO VALEANT ON (B)(6) 2014. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2014 AND FORWARDED TO VALEANT ON (B)(6) 2014. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2014 AND FORWARDED TO VALEANT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409698 SCULPTRA, POLY-L-LACTIC ACID INJECTABLE DERMAL FILLER LMH VALEANT PHARMACUETICALS NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other