BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1882345 · Received October 22, 2010

    Report

    Report Number
    3003496686-2010-62794
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 22, 2010
    Manufacturer
    SANOFI AVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 (B)(6) 2010 (LOCAL REFERENCE (B)(4)). THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) ON (B)(6) 2010. IT WAS RECONSTITUTED ON THE (B)(6) 2010 WITH 5ML SWFI (STERILE WATER FOR INJECTION) AND 2ML XYLOCAINE. THIS WAS THE PT'S 3RD VIAL OF POLY-L-LACTIC ACID. RELEVANT MEDICAL HISTORY INCLUDES HERPES AND DENTAL TREATMENT. RELEVANT CONCOMITANT MEDICATIONS WERE NOT MENTIONED. THE PATIENT DEVELOPED A BIG RED MARK ON ONE SIDE OF HER FACE ON THE (B)(6) 2010 WHICH WAS SOMEWHAT PAINFUL & TENDER TO TOUCH. ON THE (B)(6) 2010, THE AREA HAD LITTLE BLISTERS THAT WERE SPREAD OUT. ON THE (B)(6) 2010, THE BLISTERS HAD STARTED TO WEEP AND ON THE (B)(6) 2010, THE PHYSICIAN EXAMINED THE PT AND BELIEVED THAT THE PT'S CONDITION WAS DUE TO (B)(6) AND THAT THE INJECTING SESSION HAD TRIGGERED IT (AS WELL AS ONGOING DENTAL TREATMENT THE PT HAD IN THE SAME AREA OVER A PERIOD OF SIX MONTHS PRIOR). THE PT ALSO INDICATED THAT THE AREA WAS TIGHT AND TINGLY ON THE (B)(6) 2010. THE PT WAS TREATED WITH (B)(6) AND BY THE (B)(6) 2010, THE PT WAS IMPROVING. ACTION TAKEN: UNK. OUTCOME - RECOVERING/RESOLVING. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(6) 2010: THE EVENT OF (B)(6) IS UNLISTED FOR POLY-L-LACTIC ACID. AS NOTED BY THE RPTR, THE PT HAS A HISTORY OF PREVIOUS FLARES FOLLOWING DENTAL MANIPULATION IN THE SAME AREA, AND IN THIS INSTANCE THE TRAUMA OF INJECTION COULD BE A PRECIPITATING FACTOR. THIS EVENT IS CONSIDERED SERIOUS BASED ON THE COMPANY'S DEVICE REPORTING TREE DUE TO THE USE OF ORAL ANTIVIRAL THERAPY.

    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 A9030

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN