BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1772160 · Received July 26, 2010

    Report

    Report Number
    3003496686-2010-42436
    Event Type
    Injury
    Date Received
    July 26, 2010
    Report Date
    July 23, 2010
    Manufacturer
    SANOFI-AVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    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 FROM (B)(6) WAS RECEIVED FROM A PHYSICIAN ON 16-JUL-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 CASE (B)(4) BY REPORTER. THIS CASE INVOLVES A PATIENT (AGE AND GENDER NOS) WHO INITIATED POLY-L-LACTIC ACID (SCULPTRA) THERAPY ON AN UNKNOWN DATE. NO TREATMENT DETAILS WERE PROVIDED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED PALPABLE NODULES AFTER TREATMENT WITH POLY-L-LACTIC ACID. THE REPORTER STATED THAT THESE "WERE NOT A PROBLEM." ACTION TAKEN/CORRECTIVE TREATMENT/OUTCOME - UNKNOWN. PHYSICIAN/REPORTER CAUSALITY: NOT PROVIDED.

    Devices

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

    Patients

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