BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1944459 · Received December 28, 2010

    Report

    Report Number
    3003496686-2010-68755
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    January 1, 2010
    Report Date
    December 28, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(6) 2010: INJECTION SITE ABSCESS IS A LISTED EVENT FOR POLY-L-LACTIC ACID. THIS CASE INCLUDES INSUFFICIENT INFORMATION FOR A CAUSAL ASSESSMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS UNSOLICITED REPORT WAS REC'D FROM A PHYSICIAN VIA OUR AFFILIATE IN (B)(4) ON (B)(6) 2010. THIS REPORT IS 2 OF 4 CASES. ASSOCIATED REPORTS: (B)(4). A PTC (PRODUCT TECHNICAL COMPLAINT) HAS BEEN INITIATED FOR THIS REPORT: (B)(4). THIS REPORT INVOLVES A FEMALE PT (AGE NOT PROVIDED) WHO WAS ADMINISTERED SCULPTRA (POLY-L-LACTIC ACID) INJECTION ON AN UNK DATE FOR AN UNK INDICATION. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS CASE INVOLVES A FEMALE PT WHO EXPERIENCED AN ABSCESS (NOS) IN 2010 AFTER SHE WAS INJECTED WITH POLY-L-LACTIC ACID. NO OTHER INFORMATION WAS PROVIDED. ACTION TAKEN: UNK. CORRECTIVE TREATMENT - UNK. OUTCOME - UNK. PHYSICIAN/REPORTER CAUSALITY: NOT INDICATED. ADDENDUM (B)(6) 2010: A CLUSTER OF FOUR REPORTS OF ABSCESS FORMATION (ASSOCIATED REPORTS: (B)(4)) FROM A SINGLE REPORTER IS CONSIDERED TO REPRESENT AN EVENT OF INCREASED FREQUENCY UNDER THE SCULPTRA CONDITION OF APPROVAL. PLEASE NOTE THAT CASE (B)(4) IS CLASSIFIED AS A RUMOR CASE SINCE THERE IS NO SINGLE IDENTIFIABLE PT. ADDITIONAL INFORMATION WAS REC'D FROM THE PHYSICIAN ON (B)(6) 2010. ADDITIONAL INFORMATION REC'D ON (B)(6) 2010, CORRESPONDING TO THE ADR FORM FILLED-IN BY THE PHYSICIAN. SEVERAL FIELDS WERE UPDATED (PT PROFILE, MEDICAL HISTORY, DETAILS OF ADVERSE EVENT, DETAILS OF TREATMENT AND CORRECTIVE TREATMENT AND NUMBER OF RELATED CASES). BASED ON THIS NEW INFORMATION, THE CASE WAS UPGRADED FROM NONSERIOUS TO SERIOUS PER THE COMPANY'S SCULPTRA WORKSHEET. THIS CASE INVOLVES A (B)(6) FEMALE PT WHO WAS INJECTED POLY-L-LACTIC ACID SCULPTRA ON (B)(6) 2010. THE PT EXPERIENCED ABSCESS OF 4 CM IN DIAMETER LOCATED IN RIGHT ARM FROM (B)(6) 2010. DETAILED INDICATION WAS SKIN TONE UP. TREATMENT DETAILS: ON (B)(6) 2010. DILUTION VOLUME: STERILE WATER (10ML). AMOUNT INJECTED: 3ML NOS. BATCH NUMBER: (A9033, EXP DATE NOV-2011). REGION(S) INJECTED: LEFT AND RIGHT ARM. CORRECTIVE TREATMENT: INTRALESIONAL INJECTION OF CORTICOSTEROIDS (TRIAMCINOLONE (B)(6)) AND ANTIBIOTICS PO AND/OR IV (CEFALEXIN (KEFLORIDINA) 500 MG NOS). REGARDING SERIOUSNESS CRITERIA, ACCORDING TO THE PHYSICIAN, THE ADVERSE EVENT DID NOT LEAD TO PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. REGARDING NEED OF SURGICAL INTERVENTION, THE PHYSICIAN ANSWERED NO. OUTCOME: RECOVERED. THIS IS THE SECOND CASE OF 5 CASES WHICH ARE LINKED SINCE THE REPORTER IS THE SAME. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other PREV MEDS = UNK| WATER FOR INJECTION (CON.)