BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 2801176 · Received October 17, 2012

    Report

    Report Number
    3002807108-2012-73007
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 17, 2012
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED ON (B)(6) 2012: THIS SPONTANEOUS CASE WAS REPORTED BY A GYNAECOLOGIST WHO REPORTED ABOUT HERSELF. IN (B)(6) 2010 AND (B)(6) 2011 SHE WAS TREATED BY A PAEDIATRICIAN WITH POLY-L-LACTIC ACID (SCULPTRA, BATCH # UNK) FOR COSMETIC SKIN PROCEDURE. TREATED AREAS: NASOLABIAL FOLDS AND AREA OF CHEEK. STARTING IN (B)(6) 2011, THE GYNAECOLOGIST RECOGNIZED TWO SMALLER NODULES AT THE NASOLABIAL FOLD. MASSAGE OF THE APPLICATION AREA OF POLY-L-LACTIC ACID WAS RECOMMENDED. STARTING IN (B)(6) 2012, THE GYNAECOLOGIST EXPERIENCED APPROX 30 COMPACT, BLUISH, TACTILE, AND PARTLY VISIBLE NODULES (LOCATION: CHEEK). THE NODULES HAD THE SIZE OF A LENTIL UP TO A PEA. CORRECTIVE TREATMENT INCLUDED DOXYCYCLINE AT A DAILY DOSE OF 100 MG FOR APPROX TWO WEEKS. PREVIOUS ANAESTHETIC TREATMENT WAS DENIED. MEDICAL HISTORY WAS UNEVENTFUL. OUTCOME WAS NOT REPORTED. IN CASE OF NO SUCCESS, FURTHER CORRECTIVE TREATMENT WITH GLUCOCORTICOIDS IS UNDER DISCUSSION. A PRODUCT-TECHNICAL EXAMINATION (GLOBAL PTC #(B)(4)) WAS INITIATED. ASSESSMENT AFTER INVESTIGATION: AN INVESTIGATION HAS BEEN PERFORMED AND THE RESULTS ARE DISCUSSED HERE AS FOLLOWS: SINCE NO BATCH NUMBER WAS COMMUNICATED, THE DOCUMENTATION RELEVANT TO ALL THE SCULPTRA BATCHES MARKETED IN (B)(4) AND NOT YET EXPIRED WAS RE-CONTROLLED. FOR EACH BATCH, BOTH SEMI-FINISHED AND FINISHED (PACKAGING) DOCUMENTATIONS HAVE BEEN RE-CHECKED AND NO ANOMALIES LINKED TO THE EVENT REPORTED HAVE BEEN PICKED OUT. THE VERIFIED BATCHES WERE: A0035, A0036, A0037, A0038, A0039, A1040, A1041, A1042, A1043, A1044, A1045, A1D48, A1046, A1047, A1048, A2051, A2052, A2053, A2054 AND A2056. THE ANALYSIS CERTIFICATE AT THE RELEASE STEP OF ALL THE BATCHES LISTED ABOVE HAS BEEN RE-CHECKED AND ALL THE RESULTS WERE CONFORMING TO SPECS. THE INVESTIGATION DID NOT POINT OUT ANOMALIES RELATED TO THE QUALITY OF THE BATCHES RELEASED FOR THE MARKET, NEVERTHELESS, SINCE ANAGNI IS NOT RESPONSIBLE FOR MEDICAL EVALUATIONS, WE RESERVE TO CLOSE THIS COMPLAINT AS "NO CONCLUSION POSSIBLE". ADD'L INFO RECEIVED FROM INVESTIGATION SITE ON (B)(6) 2012. ASSESSMENT AFTER INVESTIGATION ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA (POLY-L-LACTIC ACID) FACIAL FILLER LMH AVENTIS PHARMA GRUPPO LEPETIT S.R.L. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R PREV MEDS = UNK| CON MEDS = UNK