BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 2772053 · Received October 1, 2012

    Report

    Report Number
    3002807108-2012-68805
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 1, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BELOW NARRATIVE INCLUDES AN INITIAL REPORT REPORTED BY A PHYSICIAN TO A (B)(6) SALES REPRESENTATIVE ON (B)(6) 2012, PLUS SUBSEQUENT FOLLOW-UP: THE PHYSICIAN REPORTED THAT A (B)(6) MALE PT WAS TREATED WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) IN BOTH CHEEKS IN (B)(6) 2011. THE PT THEN RECEIVED INTENSIVE PULSE LIGHT (IPL) ON (B)(6) 2012, AND HE DEVELOPED BILATERAL EDEMA IN HIS CHEEKS (B)(6) DAYS AFTER THE IPL. THE PHYSICIAN REPORTED THAT THE BILATERAL FACIAL EDEMA RESPONDED TO PREDNISONE TREATMENT, BUT THEN RELAPSED UPON PREDNISONE DISCONTINUATION. ON AN UNSPECIFIED DATE, THE PHYSICIAN WAS INFORMED BY THE PT THAT HE HAD DEVELOPED NODULES AND OR PAPULES ON HIS FACE SHORTLY AFTER RECEIVING THE IPL. APPROXIMATELY 18 MONTHS AFTER THE LAST POLY-L-LACTIC ACID TREATMENT IN (B)(6) 2011, THE PT EXPERIENCED A PERSISTENT LOCALIZED SENSITIVITY ON BOTH CHEEKS ((B)(6) 2012). NO FURTHER RELEVANT INFORMATION PROVIDED. ADDITIONAL INFORMATION FOR SCULPTRA (LOT # AND EXPIRATION DATE UNKNOWN) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE ID (B)(4) DATED (B)(6) 2012, RECEIVED BY (B)(6) ON (B)(6) 2012: 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 STILL ON THE US MARKET UP TO MAY 2011 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: (B)(4). THE ANALYSIS CERTIFICATE AT THE RELEASE STEP OF ALL THE BATCHES LISTED ABOVE HAS BEEN RE-CHECKED AND ALL THE RESULTS WERE CONFORMING TO SPECIFICATIONS. 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. CONCLUSION: NO INVESTIGATION POSSIBLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012: PT DEMOGRAPHICS; THERAPY DATES FOR POLY-L-LACTIC ACID (SCULPTRA AESTHETIC); NEW EVENTS; AND CORRECTIVE TREATMENT WERE ALL ADDED; OUTCOME OF THE CASE WAS UPDATED TO NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH AVENTIS PHARMA GRUPPO LEPETIT S.R.L. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN