BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1844904 · Received September 23, 2010

    Report

    Report Number
    3003496686-2010-52302
    Event Type
    Injury
    Date Received
    September 23, 2010
    Report Date
    September 23, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS RECEIVED FROM A PHYSICIAN ON 01-SEP-2010 AND UPON MEDICAL REVIEW, HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT(S) FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE (B)(4). THIS CASE IS ASSOCIATED TO CASES (B)(4) AND (B)(4) BY REPORTER. THIS CASE INVOLVES A FEMALE, PT, WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) THERAPY IN 2008. NO ADDITIONAL TREATMENT DETAILS WERE PROVIDED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFO WERE NOT MENTIONED. ON AN UNSPECIFIED DATE, THE PT PRESENTED WITH A GRANULOMA ON APPLICATION SITES (NOS). AS CORRECTIVE CONDUCT, THE PT RECEIVED A CORTICOID (UNSPECIFIED) AND SHE FULLY RECOVERED FROM THE EVENT. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: (B)(4). PHYSICIAN'S CAUSALITY ASSESSMENT: NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA (POLY-L-LACTIC ACID) FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC UNK

    Patients

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