BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 1734010 · Received December 21, 2009

    Report

    Report Number
    3002807108-2009-00783
    Date Received
    December 21, 2009
    Report Date
    March 9, 2009
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    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. SINCE NO LOT NUMBER IS AVAILABLE, AN INVESTIGATION HAS BEEN PERFORMED ON THE DOCUMENTATION OF ALL POTENTIALLY INVOLVED MANUFACTURED BATCHES MARKETED IN THE (B)(6). THE REVIEW OF THE DHR (DEVICE HISTORY RECORDS) AND OF THE ANALYTICAL RESULTS OF THESE BATCHES 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. CONCLUSION: NO FAULTS DETECTABLE. REPORTER'S CAUSALITY ASSESSMENT: NOT PROVIDED.

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS REPORTED BY A NURSE VIA A COMPANY REPRESENTATIVE AND FORWARDED BY OUR LOCAL AFFILIATE (B)(4). INITIAL AND FOLLOW-UP INFORMATION RECEIVED ON 09-MAR AND 16-MAR-09 RESPECTIVELY WERE PROCESSED TOGETHER. THIS CASE INVOLVES A FEMALE PATIENT (AGE NOS) WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) THERAPY SOMETIME IN 2008. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. ON AN UNKNOWN DATE THE PATIENT DEVELOPED VISIBLE LUMPS IN HER CHEEKS. THE PATIENT SAW A PLASTIC SURGEON WHO HAS INJECTED HYDROLASE INTO HER CHEEK. THE PATIENT HAS ALSO TRIED LASER TREATMENT ON HER SKIN TO SMOOTH IT OUT. EVENT OUTCOME IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK