BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1483927 · Received September 24, 2009

    Report

    Report Number
    3002807108-2009-00050
    Event Type
    Injury
    Date Received
    September 24, 2009
    Date of Event
    June 1, 2009
    Report Date
    September 8, 2009
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY//SANOFI-AVENTIS
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED FROM A PHYSICIAN VIA A SALES REPRESENTATIVE ON 08-SEP-2009: A FEMALE PATIENT OF AN UNKNOWN AGE WAS TREATED WITH A POLY-L-LACTIC ACID [SCULPTRA] (LOT # AND EXPIRATION DATE NOT PROVIDED) INJECTION ON AN UNSPECIFIED DATE IN 2008 FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE IN 2009, THE PATIENT PRESENTED WITH BUMPS. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE NOT PROVIDED. NO FURTHER RELEVANT INFORMATION REPORTED. ADDITIONAL INFORMATION FOR SCULPTRA (LOT # AND EXPIRATION DATE: NOT PROVIDED) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE DATED 12-SEP-2009, RECEIVED BY ON 16-SEP-2009: BATCH RECORD REVIEW WAS WITHOUT HINT TO ROOT CAUSE. BECAUSE NO LOT NUMBER IS AVAILABLE, AN INVESTIGATION HAS BEEN PERFORMED ON THE DOCUMENTATION OF ALL POTENTIALLY INVOLVED MANUFACTURED BATCHES. THE REVIEW OF THE DEVICE HISTORY REPORT AND OF THE ANALYTICAL RESULTS OF THESE BATCHES DID NOT SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT WHICH OCCURRED. THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT IS NOT BATCH RELATED. CONCLUSION: NO FAULTS DETECTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA INJECTABLE LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY//SANOFI-AVENTIS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK