BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1658698 · Received April 12, 2010

    Report

    Report Number
    3003496686-2010-18481
    Event Type
    Injury
    Date Received
    April 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    April 12, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 31-MAR-10, DEVICE QC PERFORMED. ON 09-APR-10, DEVICE QC PERFORMED.

    Description of Event or Problem · 1

    INITIAL REPORT: THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN (SURGEON) WITH LIMITED INFORMATION ONLY. TWO AND A HALF YEARS AGO, A PATIENT HAD BEEN TREATED WITH POLY-L-LACTIC ACID (SCULPTRA). THE PATIENT CONTACTED THE PHYSICIAN BECAUSE OF EXTENDED FORMATION OF GRANULOMA. FURTHER INFORMATION WAS NOT PROVIDED. CASE UPGRADED TO SERIOUS UPON ADDITIONAL INFORMATION RECEIVED ON 7-APR-2010 FROM PHYSICIAN (SURGEON): THE PHYSICIAN COULD NOT PROVIDE FURTHER INFORMATION CONCERNING THE APPLICATION OF POLY-L-LACTIC ACID SINCE THE PROCEDURE WAS PERFORMED BY ANOTHER OPERATOR (UNKNOWN). BECAUSE OF SEVERAL NON-VISIBLE NODULES THE PATIENT HAD BEEN TREATED OBVIOUSLY WITH CORTISONE INJECTIONS WHICH CAUSED NECROSIS OF FAT TISSUE. ADDITIONAL INFORMATION RECEIVED ON 9-APR-2010 / ASSESSMENT AFTER PTC INVESTIGATION: BATCH RECORD REVIEW WITHOUT HINT TO ROOT CAUSE. CONCLUSION: NO FAULTS DETECTABLE.

    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 PREV MEDS = UNK| CON MEDS = UNK