BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)

    MDR report key: 1651251 · Received April 2, 2010

    Report

    Report Number
    3003496686-2010-17912
    Event Type
    Injury
    Date Received
    April 2, 2010
    Date of Event
    March 10, 2010
    Report Date
    April 2, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THE INITIAL REPORT AND FOLLOW-UP REPORTS RECEIVED ON 26-MAR-2010, 29-MAR-2010, AND 31-MAR-2010 RESPECTIVELY WERE PROCESSED TOGETHER. THIS NON-SERIOUS CASE FROM (B) (6) WAS RECEIVED FROM A PHYSICIAN ON 26-MAR-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). ASSOCIATED TO CASE (B) (4) (SAME REPORTER). OF NOTE, THE VIAL INJECTED (INTO THIS PT) WAS FROM THE SAME BOX AS (B) (4). ONE VIAL WAS ADMINISTRATED TO EACH PT. THIS CASE INVOLVES A (B) (6) FEMALE PT WHO RECEIVED TWO POLY-L-LACTIC ACID (SCULPTRA) INJECTIONS (ON (B) (6) 2009 AND (B) (6) 2010). ON (B) (6)2010, THE PT DEVELOPED 4-5 RED HOT VISIBLE NODULES OF BIG SIZE THAT WERE INCREASING IN HARDNESS AND SIZE. THESE NODULES WERE LOCATED ON COMMISSURES AND LINE OF THE RINGS UNDER THE EYES. CORRECTIVE TREATMENT: (B) (6) 2010: INTRALESIONAL INJECTION OF CORTICOSTEROIDS, 5-FU (NOT SPECIFIED WHICH ONE OR WHETHER BOTH) AND CORTICOSTEROIDS: DEXAMETHASONE (NOS) 1MG/12 (ORAL OR IV, ROUTE NOT SPECIFIED). OTHER TREATMENTS INCLUDE RADIO FREQUENCY. ACCORDING TO THE REPORTER, THE EVENT DID NOT LEAD TO PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. NO BIOPSY WAS PERFORMED AND NO SURGICAL INTERVENTION WAS REQUIRED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFO WERE NOT MENTIONED. ACTION TAKEN: NOT APPLICABLE. OUTCOME - RECOVERING/RESOLVING. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: (B) (4). PHYSICIAN/REPORTER CAUSALITY: PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY-L-LACTIC ACID (POLY-L-LACTIC ACID) FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC 1A8026

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other PREV MEDS = UNK| CON MEDS = UNK