BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCULPTRA

    MDR report key: 1023749 · Received March 19, 2008

    Report

    Report Number
    3002807108-2008-00012
    Event Type
    Other
    Date Received
    March 19, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 5, 2008
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT 05-MAR-08: THIS COHORT IS A (B) (4) PROSPECTIVE OBSERVATIONAL STUDY IN (B) (6) PATIENTS RECEIVING (B) (6) DRUGS AND TREATED WITH POLY-L-LACTIC ACID FOR FACIAL LIPOATROPHY. ITS MAIN AIM IS TO DESCRIBE THE SAFETY OF POLY-L-LACTIV ACID IN THE TREATMENT OF THE FACIAL LIPOATROPHY IN (B) (6) PATIENTS. A (B) (6) MALE WITH HISTORY OF (B) (6) HAD RECEIVED FOUR INJECTIONS OF POLY-L-LACTIC ACID (NEW-FILL) FOR LIPOATROPHY, RESPECTIVELY ON (B) (6) 2007, ON (B) (6) 2007, ON (B) (6) 2007 AND ON (B) (6) 2008. DURING THE LAST INJECTION OF NEWFILL WITH LIDOCAIN, EPHINEPHRIN THE PHYSICIAN SAW PALLOR AT INJECTION SITE IN RIGHT CHEEK. AFTER THESE LAST INJECTIONS ON (B) (6) 2008, THE PATIENT DEVELOPED WHITE CUTANEOUS PLAQUE ON THE RIGHT CHEEK WITH SUPERFICIAL SECOND DEGREE BURN ASPECT FOR 10 OR 11 DAYS. THE PHYSICIAN REPORTED SCABS WHICH DISAPPEARED WITHIN TWO OR THREE WEEKS ACCORDING TO THE PATIENT. THE PHYSICIAN DID NOT SEE HIS PATIENT AT THIS TIME. NO CORRECTIVE TREATMENT WAS INITIATED. AT CONSULTATION, EXAMINATION REVEALED HEALING OF RIGHT CHEEK BUT WITH VISIBLE SUPERFICIAL RETICULUM AS TELANGECTASIES ? OTHERWISE THE PATIENT HAD NOT ANY OTHER LOCALIZED CUTANEOUS LESIONS WHILE HE WAS KNOWN TO HAVE (B) (6) WITHOUT ACTIVE PHASE AT THE CONSULTATION TIME. BY PHONE THE PHYSICIAN REPORTED SKIN ATROPHY AS SEQUELAE. BATCH NUMBER WAS A6015. (B) (4). MANUFACTURER'S PRELIMINARY COMMENTS: THIS ADVERSE EVENT IS NOT CONSIDERED TO BE RELATED TO A QUALITY DEFECT, MALFUNCTION, OR DEFICIENCY. THERE WAS ONLY ONE OTHER CASE OF INJECTION SITE NECROSIS REPORTED FROM THE USA IN (B) (6) 2006. THIS ADVERSE EVENT IS CONSIDERED UNLISTED IN THE PRODUCT LABELING. NECROSIS IS CONSIDERED TO BE RELATED TO INJECTION TECHNIQUE (E.G. INJECTING INTO A BLOOD VESSEL) RATHER THAN RELATED TO THE POLY-L-LACTIC ACID. OF NOTE, FURTHER INFORMATION IS NEEDED TO CONFIRM THE EVENT OF SKIN NECROSIS (IT'S OCCURRENCE IS QUESTIONABLE ACCORDING TO THE AVAILABLE DATA).

    Description of Event or Problem · 1

    (B) (4). INITIAL PHONE INFO RECEIVED FROM A PHYSICIAN ON 05-MAR-2008, WRITTEN ADDITIONAL INFO ON 06-MAR-2008, ALL INFO WAS ASSESSED AT THE SAME TIME. THIS COHORT IS A (B) (4) PROSPECTIVE OBSERVATIONAL STUDY IN (B) (6) PATIENTS RECEIVING (B) (6) DRUGS AND TREATED WITH POLY-L LACTIC ACID FOR FACIAL LIPOATROPHY. ITS MAIN AIM IS TO DESCRIBE THE SAFETY OF POLY-L-LACTIC ACID IN THE TREATMENT OF THE FACIAL LIPOATROPHY IN (B) (6) PATIENTS. A (B) (6) MALE PT WITH MEDICAL HISTORY OF (B) (6) HAS RECEIVED FOUR INJECTIONS OF POLY-L-LACTIC ACID (NEW-FILL) FOR LIPOATROPHY, RESPECTIVELY ON (B) (6) 2007, ON (B) (6) 2007, ON (B) (6) 2007 AND ON (B) (6) 2008. CONCOMITANT MEDICATIONS INCLUDED EMBRICITABINE (EMTRIVA) PO, TIPRANAVIR (APTIVUS) PO, RITONAVIR (NORVIR) PO AND ENFUVIRTIDE (FUZEON) PO ; FOR ALL DRUGS EXACT DOSES WERE NOT PROVIDED. DURING THE LAST INJECTION OF NEWFILL WITH XYLOCAIN ADRENALIN (LIDOCAIN, EPINEPHRIN) THE PHYSICIAN SAW PALLOR AT INJECTION SITE IN RIGHT CHEEK (NOTHING ON LEFT CHEEK WITH THE SAME INJECTION COMPOSITION). AFTER THESE LAST INJECTIONS ON (B) (6) 2008, THE PATIENT DEVELOPED WHITE CUTANEOUS PLAQUE ONLY ON RIGHT CHEEK WITH SUPERFICIAL SECOND DEGREE BURN ASPECT FOR 10 OR 11 DAYS. BY PHONE THE PHYSICIAN REPORTED SCABS WHICH DISAPPEARED WITHIN TWO OR THREE WEEKS ACCORDING TO THE PATIENT, THE PHYSICIAN DID NOT SEE HIS PATIENT AT THIS TIME. NO CORRECTIVE TREATMENT WAS INITIATED. AT CONSULTATION, EXAMINATION REVEALED HEALING OF RIGHT CHEEK BUT WITH VISIBLE SUPERFICIAL RETICULUM AS TELANGECTASIES ? OTHERWISE THE PATIENT HAD NOT ANY OTHER LOCALIZED CUTANEOUS LESIONS WHILE HE WAS KNOWN TO HAVE (B) (6) WITHOUT ACTIVE PHASE AT THE CONSULTATION TIME. BY PHONE THE PHYSICIAN REPORTED SKIN ATROPHY AS SEQUELAE. BATCH NUMBER WAS A6015. (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR