BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 2122195 · Received May 27, 2011

    Report

    Report Number
    3003496686-2010-70762
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    November 10, 2010
    Report Date
    May 27, 2011
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT (B)(4)-2011: THIS CASE DESCRIBED A FEMALE PT, WHO REPORTED INJECTION SITE NERVE DAMAGE ONE WEEK AFTER RECEIVING POLY-LACTIC ACID INJECTION. WITHOUT CONFIRMATION FROM THE TREATING PHYSICIAN AND OUTCOME OF EVENT, A CAUSAL ASSESSMENT IS LIMITED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    INITIAL INFO WAS RECEIVED FROM A PHYSICIAN ON (B)(6)-2010: A (B)(6) FEMALE PT RECEIVED HER FIRST INJECTION WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # A0034, EXP DATE 31-DEC-2012) FOR COSMETIC USE ON (B)(6)-2010. SHE RECEIVED IT ALONG WITH LIDOCAINE. THE PHYSICIAN STATED THAT THE TREATMENT SESSION WENT WELL BUT REPORTED THAT AT THE END OF THE SESSION THE PT HAD LITTLE LEFT CHEEK PALSY OF THE FACIAL NERVE AND THE PT'S SMILE WAS CROOKED. THE PHYSICIAN EXPLAINED THAT THIS SOMETIMES HAPPENS DUE TO THE INJECTIONS AND THE LIDOCAINE. THE PHYSICIAN ALSO STATED THAT THE PT DID NOT HAVE A LOT OF BRUISING. THE DAY AFTER THE TREATMENT ((B)(6)-2010), HER SMILE WAS BACK TO NORMAL. THE PT WAS A LITTLE ACHY AND PUFFY IN THE INJECTION AREA. THE PHYSICIAN STATES THIS PT'S SYMPTOMS FLARED ONE WEEK AFTER THE INJECTION SESSION AND ON (B)(6)-2010, THE PT CALLED THE PHYSICIAN COMPLAINING OF SHARP PAIN IN THE LEFT CHEEK AREA AND BEING UNABLE TO SLEEP. THE PHYSICIAN SAW HER ON THAT DAY ((B)(6)-2010) AND THE PT STATED THAT SHE HAD SHOOTING PAIN WHEN SHE SMILED AND THE PAIN WAS CONSTANTLY THERE. SHE HAD NO FEVER, CHILLS OR SIGNS OF INFECTION. THE PT BELIEVED THAT THE PHYSICIAN DAMAGED THE NERVE AND THAT SHE NOW HAD A SYNDROME RELATED TO THIS. THE PHYSICIAN REPORTEDLY HAS USED POLY-L-LACTIC ACID FOR MANY YRS, SINCE IT CAME ON THE MARKET. NO FURTHER RELEVANT INFO WAS REPORTED. ADDITIONAL INFO FOR SCULPTRA (LOT# A0034 AND EXP DATE: 31-DEC-2012) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE ID (B)(4), DATES (B)(6)-2010, RECEIVED BY (B)(6) ON (B)(6)-2010: BATCH RECORD REVIEW WAS WITHOUT HINT TO ROOT CAUSE. THE REVIEW OF THE DEVICE HISTORY REPORT AND OF THE ANALYTICAL RESULTS OF THE INVOLVED BATCH DID NOT SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT WHICH OCCURRED. THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT IS NOT BATCH RELATED. CONCLUSION: NO FAULTS DETECTABLE. ADDITIONAL INFO AS RECEIVED BY A SALES REP FROM A PHYSICIAN ON (B)(6)-2011: THIS FEMALE PT RECEIVED INJECTION WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) IN (B)(6) 2010 (REPORTED FROM PHYSICIAN AS (B)(6)-2010). THE PHYSICIAN INJECTED THE PT ON THE RIGHT SIDE OF THE FACE UNDER THE ZYGOMATIC ARCH. SINCE THEN, THE PHYSICIAN REPORTED THAT SHE WAS HAVING PROBLEMS WITH THE PT. THE PT REPORTED NUMBNESS AND NERVE DAMAGE AT THE SIGHT OF THE INJECTIONS. THE PHYSICIAN TRIED TO REACH BACK OUT TO THE PT TO RECTIFY THE SITUATION BUT WAS NOT ABLE TO GET BACK TO THE PT. THE PT'S SISTER IS A DERMATOLOGIST SO SHE MAY HAVE GONE TO HER SISTER FOR TREATMENT. NO FURTHER RELEVANT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC A0034

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other PREV MEDS = UNK| LIDOCAINE (CON.)