BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1944460 · Received December 28, 2010

    Report

    Report Number
    3003496686-2010-77395
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    October 27, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPORTANT MEDICAL EVENT.

    Description of Event or Problem · 1

    THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS RECEIVED FROM A PHYSICIAN ON (B)(6) 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). THIS CASE INVOLVES AN ADULT MALE PT (AGE NOS) WHO WAS INJECTED POLY-L-LACTIC ACID (SCULPTRA) ON (B)(6) 2010. THE PT EXPERIENCED ABSCESS OF 7-8 CM IN DIAMETER ON THE RIGHT OF THE FACE, AFFECTING THE WHOLE RIGHT SIDE OF THE FACE, FROM (B)(6) 2010 TO (B)(6) 2010. DETAILED INDICATION WAS CHEEKBONE LIPOATROPHY. NO BIOPSY WAS TAKEN. TREATMENT DETAILS: (B)(6) 2010: DILUTION VOLUME: STERILE WATER (NOS). AMOUNT INJECTED: 5 ML (NOS). BATCH NUMBER: (A9033, EXP. DATE NOV-2011). REGION(S) INJECTED: RIGHT CHEEKBONE. CORRECTIVE TREATMENT: INTRALESIONAL INJECTION OF CORTICOSTEROIDS (TRIAMCINOLONE (TRIGON DEPOT)) AND ANTIBIOTICS PO AND/OR IV (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 YES (PRODUCT DRAINAGE). SERIOUSNESS CRITERIA AS PER REPORTER: NOT SPECIFIED. CAUSAL RELATIONSHIP: NOT SPECIFIED. OUTCOME: RECOVERED. THIS IS THE FIFTH 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 A9033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ANTIDEPRESSANTS (CON) UNK| PREV MEDS = UNK