BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA, POLY-L-LACTIC ACID

    MDR report key: 3142060 · Received May 29, 2013

    Report

    Report Number
    3009443653-2013-00100
    Date Received
    May 29, 2013
    Date of Event
    July 1, 2012
    Report Date
    May 13, 2013
    Manufacturer
    VALEANT USA
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PB (B)(6) 2013. THE EVENTS: FEVER, EAR ACHE, SORE THROAT, FOREIGN BODY REACTION, NEUROLOGIC FATIGUE WERE ASSESSED AS A NON SERIOUS, UNEXPECTED AND POSSIBLY RELATED TO USE OF MEDICINAL PRODUCT. THE EVENT: PAIN WAS ASSESSED AS A NON SERIOUS, EXPECTED AND POSSIBLY RELATED TO USE OF MEDICINAL PRODUCT. GRANULOMATOUS REACTION AND EXACERBATION OF AUTOIMMUNE DISORDER ASSESSED AS SERIOUS, UNEXPECTED AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2013, FROM A (B)(6) FEMALE PT IN THE FORM OF MEDICAL RECORDS. THE PT HAD MEDICAL HISTORY OF GRAVES DISEASE, BREAST CANCER, LEFT BREAST LUMPECTOMY, AND CHRONIC ORAL HSV, MULTIPLE SCLEROSIS, RETINAL DETACHMENT, SINUSITIS, ARTHRITIS, HASHIMOTO'S DISEASE, OPTIC NEURITIS, PNEUMONIA, BRONCHITIS, URINARY TRACT INFECTION, FIBROMYALGIA, SCIATICA AND SHINGLES. PAST SURGICAL HISTORY: INCLUDE NECK FUSION IN 1991, DETACHED RETINA IN 2001, LUMPECTOMY X2 FOR BREAST CANCER IN 2011, APPENDECTOMY 1988. FAMILY HISTORY: MOTHER, CONGESTIVE HEART FAILURE, AGO (B)(6). FATHER DIED AT AGE OF (B)(6) OF LUNG CANCER. ONE LIVING CHILD, (B)(6) YEARS AGO. THE PT CONCOMITANT MEDICATION INCLUDED FIORICET, SOMA, PROVIGIL, SYNTHROID, ACYCLOVIR, VALTREX, COPAXONE, EYE DROPS, VITAMINS AND MINERALS. IN (B)(6) 2008, THE PT HAD SCULPTRA (POLY-L-LACTIC ACID) ACROSS NASOLABIAL FOLD FOR AN UNK INDICATION. IN (B)(6) 2012, THE PT HAD GRANULOMATOUS REACTION AND FOREIGN BODY REACTION AFTER SCULPTRA AND BIOPSY SHOWED EXTRACTED OF FOREIGN SUBSTANCE REACTION. THE PT HAD EXACERBATION OF AUTOIMMUNE DISORDER WITH FOREIGN BODY REACTION OCCURRING ON HER FACE AT THE SITE OF INJECTION. PT HAD MULTIPLE SCLEROSIS AND SHE STATED THAT SHE STARTED WITH INJECTION IN 2009, CAUSED IMMUNOLOGICAL FIRESTORM WHICH RESULTED IN MULTIPLE MEDICAL ISSUES. IN (B)(6) 2013, THE PT EXPERIENCED FEVER FEELS LIKE BURNING UP AND SICK, IT WAS REPORTED THAT FEVER NOT CO-RELATION WITH ORAL HSV AND PT ALSO EXPERIENCED PAIN, NEUROLOGIC FATIGUE, FREQUENT EAR ACHE AND SORE THROAT. THE OUTCOME OF THE EVENT WAS UNK. NO INFO ABOUT MEDICAL EVAL OR CAUSALITY ASSESSMENT WAS PROVIDED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235350 SCULPTRA, POLY-L-LACTIC ACID FACIAL IMPLANT LMH VALEANT USA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other FIORICET (AXOTAL/00727001)| (CAFFEINE, BUTALBITAL, PARACETAMOL),| RETINOL,| VALTREX (VALACICLOVIR HYDROCHLORIDE),| ASCORBIC ACID,| ACYCLOVIR (ACICLOVIR),| (10057097 - DRUG USE FOR UNK INDICATION)| (10057097 - DRUG USE FOR UNK INDICATION)| SOMA (CARISOPRODOL),| CALCIUM PHOSPHATE),| MAGNESIUM PHOSPHATE,| THIAMINE HYDROCHLORIDE,| NICOTINAMIDE,| CALCIUM PANTOTHENATE,| (10057097 - DRUG USE FOR UNK INDICATION)| SYNTHROID (LEVOTHYROXINE SODIUM),| CALCIUM GLUCONATE,| FERROUS FUMARATE,| (ERGOCALCIFEROL,| PYRIDOXINE HYDROCHLORIDE,| (10057097 - DRUG USE FOR UNK INDICATION)| (10057097 - DRUG USE FOR UNK INDICATION)| (10057097 - DRUG USE FOR UNK INDICATION)| TOCOPHEROL,| FOLIC ACID,| CYANOCOBALAMIN,| VITAMINS AND MINERALS (VITAMIN 15)| (10057097 - DRUG USE FOR UNK INDICATION)| COPAXONE (GLATIRAMER ACETATE),| RIBOFLAVIN,