BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 1741955 · Received December 21, 2009

    Report

    Report Number
    3002807108-2009-00945
    Date Received
    December 21, 2009
    Report Date
    January 9, 2008
    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

    SINCE NO LOT NUMBER IS AVAILABLE, AN INVESTIGATION HAS BEEN PERFORMED ON DOCUMENTATION OF ALL POTENTIALLY INVOLVED MANUFACTURED BATCHES MARKETED IN (B)(4). THE REVIEW OF THE DHRS (DEVICE HISTORY REPORTS) 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. THEREFORE, WE RECOMMEND TO ADDRESS THIS KIND OF EVENT TO THE MEDICAL AFFAIRS UNIT FOR THEIR EVAL. CONCLUSION: NO FAULTS DETECTABLE.

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE VIA OUR AFFILIATE IN (B)(4). THIS REPORT INVOLVES A MALE PT WHO WAS TREATED WITH NEW-FILL (POLY-L-LACTIC ACID) TWO MONTHS AGO (DOSAGE, THERAPY DATES AND INDICATION WERE NOT PROVIDED). NO CONCOMITANT MEDICATIONS WERE REPORTED. NO MEDICAL HISTORY WAS INDICATED, OTHER THAN THE PATIENT HAS USED NEW-FILL IN THE PAST. A COUPLE OF MONTHS AGO, THE PATIENT RECEIVED TREATMENT WITH NEW-FILL. AFTER A WEEK OF FINISHING TREATMENT HE INVESTED IN A SKIN CARE REGIMENT PRESCRIBED FOR HIM BY HIS GENERAL PRACTITIONER. THE PRODUCTS WERE FROM THE "MING AND MOLLY RANGE." THE PRODUCT CONTAIN 6% GLYCOLIC ACID, VITAMIN DERIVATIVE 20%, VITAMINS E AND A, GRAPE SEED EXTRACT, GREEN TEA EXTRACT, SHEA BUTTER AND PHYTIC. FOUR WEEKS AFTER HIS LAST NEW-FILL SESSION, HIS FACE SWELLED. NOW AFTER VARIOUS DIFFERENT TREATMENTS TO EXCLUDE THE EDEMA, THE NEW-FILL PRODUCT UNDERNEATH THE SKIN APPEARS TO BE HARD AND HIS FACE REMAINS SLIGHTLY SWOLLEN. AS THE PATIENT HAD ALREADY BEEN TREATED WITH NEW-FILL, THE NURSE DOUBTED THIS REACTION HAD BEEN CAUSED BY NEW-FILL. (B)(4). FURTHER INFO HAS BEEN REQUESTED. ADDENDUM FOR F/U RECEIVED ON (B)(6) 2008: FURTHER F/U WAS RECEIVED FROM THE NURSE. THIS CASE CONCERNS A (B)(6) MALE PT. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON (B)(6) 2007, THE PT RECEIVED TREATMENTS WITH NEW-FILL (POLY-L-LACTIC ACID) (BATCH #A7016, EXP 04/2009) RECONSTITUTED WITH 2 ML LIGNOCAINE AND 4 ML OF WATER. A TOTAL OF 6 ML WAS INJECTED INTO THE LEFT AND RIGHT CHEEKS. THREE WEEKS AFTER RECEIVING HIS LAST TREATMENT, THE PATIENT EXPERIENCED SWELLING AND INCREASED FACIAL EDEMA. THE PT CHANGED HIS SUN CARE RANGE ONE WEEK AFTER HIS LAST TREATMENT TO MING AND MOLLY RANGE. THE NURSE DID NOT CONSIDER THE EVENTS TO BE SERIOUS AND DID NOT THINK IF THE EVENTS OCCURRED AGAIN, IT WOULD LEAD TO DEATH OR SERIOUS INJURY. CORRECTIVE TREATMENT INCLUDED ANTI-INFLAMMATORIES AND ANTIBIOTICS. THE PATIENT HAS NOT EXPERIENCED ANY SIMILAR EVENTS AFTER TREATMENT WITH NEW-FILL/SCULPTRA OR OTHER PRODUCTS. NO HISTOLOGY OR OTHER LABORATORY TESTS WERE PERFORMED. THERE WERE NO CONCOMITANT PATHOLOGIES. ON (B)(6) 2008, THE PT'S OUTCOME WAS IMPROVED. THE NURSE STATED THAT SHE WAS UNSURE WHETHER THE REACTION WAS AN ALLERGIC ONE DUE TO THE NEW PRODUCTS INTERACTING, AS UNDERLYING INFECTION OR SOMETHING ELSE. NO FURTHER INFO IS EXPECTED. ADDENDUM DATED (B)(4) 2008: F/U INFO RECEIVED OUT OF SEQUENCE. THE RESULTS FOR (B)(4) WERE REPORTED. BRR (BATCH RECORD REVIEW) WITHOUT HINT TO ROOT CAUSE. THE BRR IS DONE ON A ROUTINE BASE DURING OUR RELEASE PROCEDURES. THE BRR WAS REPEATED CONCERNING THE REASON OF COMPLAINT. THE BRR GAVE NO INDICATIONS OF PROBLEMS DURING THE MFG PROCESS WITH REGARD TO THE REASON OF COMPLAINT. NO FAULTS, DEFECTS, DAMAGES DETECTABLE.

    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 40 YR