BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1861983 · Received October 6, 2010

    Report

    Report Number
    3003496686-2010-58862
    Event Type
    Injury
    Date Received
    October 6, 2010
    Report Date
    October 6, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS RECEIVED FROM A NURSE ON 9/30/10 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 INVOLVES A FEMALE PT WHO OVER THE LAST YEAR RECEIVED SEVERAL SESSIONS OF TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) FOR A COSMETIC INDICATION. NO ADD'L TREATMENT DETAILS WERE MENTIONED. MEDICAL HISTORY INCLUDES PREVIOUS TREATMENT WITH POLY-L-LACTIC ACID WITHOUT ANY PROBLEMS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ONE WEEK PRIOR TO THIS REPORT, THE PT PRESENTED WITH LUMPS (AREA NOT SPECIFIED). THE PT HAS TRIED MASSAGING THE AREA, BUT THIS HAS NOT HELPED. THE PT HAS BEEN REFERRED TO A DERMATOLOGIST. THERAPY WITH POLY-L-LACTIC ACID WAS REPORTED AS ONGOING. CORRECTIVE TREATMENT - UNK. OUTCOME - NOT RECOVERED/ NOT RESOLVED. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: (B)(4). REPORTER'S CAUSALITY: 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