BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1890054 · Received November 2, 2010

    Report

    Report Number
    3003496686-2010-65788
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    August 11, 2009
    Report Date
    November 2, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO WAS RECEIVED FROM A PHYSICIAN ON 26-OCT-2010: A (B)(6) FEMALE PT RECEIVED HER ONLY TREATMENT WITH TWO VIALS OF POLY-L-LACTIC ACID (SCULPTRA) (LOT # 147023), EXP DATE 30-NOV-2009) ON (B)(6) 2009 IN HER RIGHT CHEEK FOR LIFELONG IDIOPATHIC LIPODYSTROPHY. SHE COMPLAINED OF LUMPINESS AT THE INJECTION SITE AT AN OFFICE VISIT ON (B)(6) 2009 AND WAS TOLD TO MASSAGE THE SITE. SHE RETURNED ON (B)(6) 2010 STILL COMPLAINING OF LUMPS. THE PHYSICIAN INJECTED HER WITH INTRALESIONAL TRIAMCINOLONE (KENALOG) ON (B)(6) 2010 WITH NO EFFECT. THERE WAS ALSO UNSPECIFIED SURGICAL INTERVENTION DONE ON THE PT. THE PHYSICIAN REPORTED THAT THE PT CONTINUED TO HAVE PALPABLE NODULES. THE PHYSICIAN REPORTED THAT THE PT REQUESTED REIMBURSEMENT FOR HER INITIAL PAYMENT FOR POLY-L-LACTIC ACID. NO FURTHER RELEVANT INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC 147023

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other CON MEDS = UNK| PREV MEDS = UNK