BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1812051 · Received August 19, 2010

    Report

    Report Number
    3003496686-2010-48704
    Event Type
    Injury
    Date Received
    August 19, 2010
    Report Date
    August 19, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS RECEIVED FROM A CONSUMER ON 16-AUG AND OUR LOCAL QUALITY DEPARTMENT ON 17-AUG-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 A (B)(6) FEMALE PT WHO COMMENCED POLY-L-LACTIC ACID THERAPY (SCULPTRA) ABOUT A YEAR AGO. FOLLOWING SCULPTRA THERAPY, THE PT BECAME PREGNANT. NO ADDITIONAL TREATMENT DETAILS WERE MENTIONED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFO WERE NOT MENTIONED. ON AN UNK DATE, THE PT EXPERIENCED HARDENING OF POLY-L-LACTIC ACID AT THE INJECTION SITES AND DISCOLORATION OF HER SKIN AT THE INJECTION SITES IN HER CHEEKS WHICH "LOOKED LIKE BRUISING". THE PT ASSUMED AT THE TIME THAT IT WAS RELATED TO HER PREGNANCY. THE BABY WAS BORN 2.5 MONTHS AGO AND THE PT SOUGHT CORRECTIVE TREATMENT. STEROIDS WERE PRESCRIBED AND THE LUMP ON THE LEFT CHEEK "SEEMED TO HAVE BECOME INFECTED AND IS NOW VISIBLY STICKING OUT." THE REPORTER STATED "IT SEEMS INFLAMED, ANGRY, PAINFUL AND GETTING WORSE." IN TOTAL 5 POINTS WERE INFLAMED. SINCE STARTING STEROIDS, "ONE HAS GOT SMALLER, 3 HAVE STAYED THE SAME, AND THE ONE ON THE LEFT CHEEK IS PARTICULARLY PROMINENT." WHEN RECENT SWELLING STARTED, THE LUMP WAS CONSIDERED TO BE INFECTED AND ON (B)(6)2010 ANTIBIOTICS (THOUGH TO BE ERYTHROMYCIN) WAS PRESCRIBED. THE LUMP IS NOW "LARGER AND MORE PAINFUL, GETTING WORSE BY THE DAY." THE ORIGINAL POLY-L-LACTIC ACID PRACTITIONER THOUGHT PREGNANCY HORMONES MAY BE RELATED.

    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 36 YR Other