BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 1741401 · Received December 21, 2009

    Report

    Report Number
    3002807108-2009-00726
    Date Received
    December 21, 2009
    Date of Event
    July 1, 2008
    Report Date
    January 7, 2009
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO FAULTS DETECTABLE. REPORTER'S CAUSALITY ASSESSMENT: NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 21-JAN-09: THE PATIENT REPORTED VIA VOICEMAIL MESSAGE TO OUR AFFILIATE THAT SHE EXPERIENCED "QUITE A SEVERE REACTION" TO POLY-L-LACTIC ACID. SHE REPORTS HAVING SEEN A PHYSICIAN AND MENTIONED THAT HE HAD NEVER SEEN A REACTION LIKE THE ONE SHE'S HAD, WHICH SHE THINKS WAS "SOME SORT OF AN ALLERGIC REACTION." NO OTHER ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. ADDENDUM FOR FOLLOW-UP INFORMATION RECEIVED ON 23-MAR-09: THE PHYSICIAN REPORTED THAT THE RUPTURED BLOOD VESSELS ON THE FACE WERE ON THE RIGHT AND LEFT CHEEKS, AND THE SEVERITY OF THIS REACTION WAS CHARACTERIZED AS MILD. THE PATIENT IS RECOVERING FROM THIS EVENT. THE PHYSICIAN ASSESSED THE CAUSAL RELATIONSHIP FOR THIS REACTION AS UNLIKELY. THE PHYSICIAN MENTIONED THAT THE BRUISING ON THE LEFT SIDE "WAS NOT SEEN." HE ADDED THAT THE SEVERITY OF THE MASSIVE CHEEK LUMPS WAS MODERATE. THIS EVENT IS ONGOING. THE PHYSICIAN ASSESSED THE CAUSAL RELATIONSHIP FOR THIS EVENT AS HIGHLY PROBABLE. THE REPORTER STATED THAT THE LUMP UNDER THE LEFT EYE WAS LOCATED ON THE LEFT CHEEK AND HE CHARACTERIZED ITS SEVERITY AS MODERATE TOO. THIS EVENT IS ALSO ONGOING AND THE PHYSICIAN ASSESSED THE CAUSAL RELATIONSHIP AS HIGHLY PROBABLE. AS FOR THE INCREASED SINUS PAIN, THE EAR DISORDER, AND THE ECZEMA, THE PHYSICIAN STATED THAT THEY WERE "NOT SEEN" AND HE DID NOT KNOW ANYTHING ABOUT THE CAUSAL RELATIONSHIP. THE REPORTER ALSO ADDED THAT THE PATENT HAD POLY-L-LACTIC ACID LUMPS, NOT GRANULOMAS OR OTHER INFLAMMATORY REACTION. THE PHYSICIAN DID NOT KNOW ANYTHING ABOUT CONCOMITANT MEDICATIONS. HE ASSESSED THE CAUSAL RELATIONSHIP OF THE ADVERSE DRUG REACTION AS PROBABLE. ADDENDUM FOR FOLLOW-UP INFORMATION RECEIVED ON 12-MAY-2009: THE PHYSICIAN REPORTED THAT POLY-L-LACTIC ACID WAS RECONSTITUTED WITH STERILIZED WATER ONLY, 3-4 DAYS PRIOR TO ITS USE, AND HE CONFIRMED THAT LIDOCAINE (OR OTHER TOPICAL ANESTHETIC) WAS ADDED WHEN PERFORMING THE RECONSTITUTION WITH WATER. THE REPORTER INDICATED THAT THE DILUTION USED WAS 5 ML, AND MENTIONED THAT THE TOTAL VOLUME OF POLY-L-LACTIC ACID VOLUME INJECTED WAS 50 ML (5 SESSIONS OF 5 ML PER SIDE [25 ML/SIDE]).

    Description of Event or Problem · 1

    AVENTIS CASE ID: (B)(4). INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(4) WAS INITIALLY REPORTED BY A CONSUMER TO OUR UNITED STATES AFFILIATE (B)(4) AND THEN ALSO REPORTED AND FORWARDED BY (B)(4) AFFILIATE (B)(4). INITIAL AND FOLLOW-UP INFORMATION RECEIVED ON 07-JUN, 08-JAN REPORTED BY THE STUDY COORDINATOR, AND 12-JAN-2009 RESPECTIVELY WERE PROCESSED TOGETHER. THIS CASE INVOLVES A (B)(6), FEMALE, PATIENT, WHO WAS ENROLLED IN A LOCAL COMPANY SPONSORED TRIAL FOR POLY-L-LACTIC ACID (SCULPTRA) (POLY-L-01777) AND RECEIVED TREATMENT FROM (B)(6) 2007. SHE EXPERIENCED NO REACTIONS THROUGHOUT THE TRIAL WITH POLY-L-LACTIC ACID THERAPY AND ONLY EXPERIENCED THE REPORTED ADVERSE EVENTS AFTER THE END OF ENROLLMENT IN THIS STUDY. RELEVANT MEDICAL HISTORY WAS NOT REPORTED AND CONCOMITANT MEDICATIONS INCLUDED VITAMINS, PROGESTIN, AND ESTROGEN (PREMARIN). SOMETIME IN (B)(6) 2008, THE PATIENT EXPERIENCED RUPTURED BLOOD VESSELS ON HER FACE, A LOT OF BRUISING ON HER LEFT SIDE, AND MASSIVE LUMPS ON HER CHEEKS THAT WERE DESCRIBED AS "HARD AS ROCKS AND THAT LOOK LIKE SHE HAD BEEN PUNCHED IN THE FACE." SHE MENTIONED THAT SHE WEARS GLASSES TO HIDE HER FACE. SHE ALSO REPORTED HAVING A "VERY NOTICEABLE" LUMP UNDER HER LEFT EYE AND THAT HER FACE "LOOKED LIKE IT IS IN PLASTIC." SHE REPORTED THAT HER FACE IS VERY HARD AND SHE IS GETTING MORE SINUS PAIN OVER THE LAST SIX MONTHS, AS WELL AS AN INCREASED EAR DISORDER (FLUID DRAINING NOS) AND ECZEMA. SINCE (B)(6) 2008, THE PATIENT HAS BEEN RECEIVING LASER TREATMENT WITH "EPILIGHT" TO REDUCE THE APPEARANCE OF THE RUPTURED BLOOD VESSELS. AT THE TIME OF THIS REPORT, THE EVENTS REMAIN ONGOING. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: (B)(4). IT REVEALED: BRR (BATCH RECORD REVIEW) WITHOUT HINT TO ROOT CAUSE. NO FAULTS, DEFECTS, DAMAGES DETECTABLE. THE REVIEW OF THE DHR (DEVICE HISTORY RECORDS) AND OF THE ANALYTICAL RESULTS OF THE INVOLVED BATCH DIDN'T SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT OCCURRED. THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT ISN'T BATCH RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA WRINKLE FILLER LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS NA A6011

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR