BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1820711 · Received August 27, 2010

    Report

    Report Number
    3003496686-2010-50276
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 27, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED FROM A CONSUMER ON 24-AUG-2010: A FEMALE (AGE UNSPECIFIED) INITIATED THERAPY WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, LOT# AND EXP DATE UNK) AROUND (B)(6)2010. HER SECOND ROUND OF INJECTIONS WERE 8 WEEKS LATER IN (B)(6) 2010 AND HER THIRD ROUND WAS 7 WEEKS AFTER THAT IN (B)(6) 2010. THE THIRD ROUND WAS APPROXIMATELY 3 WEEKS AGO AND IS SUPPOSED TO BE HER LAST. SHE REPORTED THAT SHE IS HAVING AN ISSUE WITH HER LEFT EYELID IN THE MORNINGS. IT APPEARS "HEAVY AND "DROOPY" WHEN SHE FIRST WAKES UP, BUT IMPROVES WITH THE DAY. SHE DENIES ANY KIND OF LUMPS OR NODULES ON THE EYELID. POLY-L-LACTIC ACID WAS INJECTED IN THE "TEMPLE" AREA, NEAR "CROWS FEET". SHE ALSO STATED, SHE HAD BOTULINUM TOXIN TYPE A (BOTOX) DONE 5 WEEKS AGO. SHE FURTHER STATED THAT SHE HAD PERLANE PUT IN EYE AREA TWO YEARS AGO AND SHE "LOOKED BAD" FOR 6 MONTHS. NO FURTHER INFO REPORTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT 25-AUG-2010: THIS CASE DESCRIBED A FEMALE PT, WHO EXPERIENCED LEFT EYE PTOSIS AFTER THREE TIMES OF INJECTIONS WITH SCULPTRA NEAR "CROWS FEET" AREA. A CONFOUNDING FACTOR WAS THE RECENT INJECTION OF BOTULINUM TOXIN TYPE A- BOTOX- (LOCATION IS UNK). ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC UNK

    Patients

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