| Document Date: 2012-10-09 12:00:35
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City Bridgewater / / Company U.S. LLC / Dermik Laboratories / COS SA COS SA / Valeant Pharmaceuticals North America LLC / ALL SA COS SA / / Country United States / / Event Product Issues / / IndustryTerm injection site / magnetic resonance imaging / treatment site / healthcare / imaging / chemical peeling / geographic site / filler products / / MedicalCondition active inflammatory process / scar / inflammatory reaction / allergic reaction / headache / inflammatory process / hyperpigmentation / granuloma / hives / cysts / injection site granuloma / bronchitis / urinary tract infection / dermatitis / rheumatoid arthritis / cellulitis / skin rash / chronic / granulomatous reaction / Serious infections / colitis / syncope / fatigue / injury / hypertrophic scars / lymphadenopathy / gastritis / contour deficiency / hypersensitivity / sinusitis / pruritus / infections / telangiectasias / influenza / ectropion / upper respiratory tract infection / osteopenia / injection site eczema / Keloids / hypertension / cancer / acne / injection site abscess / skin infection / disease / tooth abscess / nasopharyngitis / gastroenteritis / hypothyroidism / folliculitis / injection site dermatitis / stroke / eczema / streptococcal infection / migraine / erythema / Itching / allergy / Serious hypersensitivity / Localized Itching / osteoarthritis / subcutaneous abscesses / pain / staphylococcal infection / myocardial infarction / toothache / urticaria / angioedema / active inflammatory conditions / skin sarcoidosis / serious pruritus / infection / active hepatitis / deficiency / respiratory infection / spider vein / inflammation / cyst / depression / keloid / few granuloma cases / rash / granulomas / connective tissue disease / herpes simplex / hypercholesterolemia / disorders / Serious erythema / / MedicalTreatment antibiotics / invasive procedures / vaccination / counseling / surgery / massage / laser treatment / immunosuppressive therapy / / Organization Blinded Evaluation Committee / / / Position investigator / counsel / physician / licensed physician / evaluator / / Product SCULPTRA Aesthetic injection / mannitol / sterile water for injection / needles / biohazards / syringes / / ProvinceOrState New Jersey / / Technology tomography / ultrasound / MRI / laser / magnetic resonance imaging / / URL www.sculptraaesthetic.com / /
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SCULPTRA® Aesthetic (injectable poly-L-lactic acid) The Sculptra Aesthetic implant package (i.e., lyophilized vials and syringe) are provided sterile. Caution: Federal (USA) law restricts this device to sale by or on th