BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 3092203 · Received February 26, 2013

    Report

    Report Number
    3009443653-2013-00001
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    August 5, 2012
    Report Date
    January 29, 2013
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOR SCULPTRA AESTHETIC (LOT # UNK AND EXPIRATION DATE: UNK) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE ID (B)(4) DATED (B)(4) 2012, RECEIVED BY (B)(4) ON (B)(4) 2012: BATCH RECORD REVIEW (BRR) WAS WITHOUT HINT TO ROOT CAUSE. AN INVESTIGATION HAS BEEN PERFORMED AND THE RESULTS ARE DISCUSSED HERE AS FOLLOWS: SINCE NO MATCH NUMBER WAS COMMUNICATED, THE DOCUMENTATION RELEVANT TO ALL THE SCULPTRA BATCHES MARKETED IN US AND NOT YET EXPIRED WAS RE-CONTROLLED. FOR EACH BATCH, BOTH SEMI-FINISHED AND FINISHED (PACKAGING) DOCUMENTATIONS HAVE BEEN RECHECKED AND NO ANOMALIES LINKED TO THE EVENT REPORTED HAVE BEEN PICKED OUT. THE VERIFIED BATCHES WERE: BATCH A0035, BATCH A0036, BATCH A0037, BATCH A0038, BATCH A0039, BATCH A1040, BATCH A1041, BATCH A1042, BATCH A1043, BATCH A1044, BATCH A1045, BATCH A1046, BATCH A1047, BATCH A1048, BATCH A2050, BATCH A2051, BATCH A2052, BATCH A2053, AND BATCH A2054. 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 THE COMPANY IS NOT RESPONSIBLE FOR MEDICAL EVALUATIONS, THE COMPLAINT WAS CLOSED AS NO CONCLUSION POSSIBLE. PHARMACOVIGILANCE COMMENT: EVENTS SWELLING OF FACE, INJECTION SITE NODULE, DEFORMITY AND DRUG INEFFECTIVE ASSESSED AS SERIOUS, EXPECTED AND POSSIBLY RELATED. SERIOUSNESS ASSESSMENT IS BASED ON MEDICAL CONFIRMATION BY THE REPORTING PHYSICIAN.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(4) 2012 FROM A CONSUMER VIA SANOFI (PARTNER COMPANY) AND CONCERNED (B)(6) FEMALE PATIENT. THE PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. THE CONCOMITANT MEDICATION OF PATIENT INCLUDED ZOLPIDEM (AMBIEN) FOR OCCASIONAL INSOMNIA. FROM (B)(6) 2012 (FIRST SESSION), TO (B)(6) 2012 (LAST SESSION), THE PATIENT HAD 2 VIALS (APPROXIMATELY 8-9 CC DILUTION PER VIAL) OF POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) INJECTED EACH TIME OVER 4 OR 5 SESSIONS IN THE HOLLOW OF HER CHEEKS, TEMPLES AND CHIN. THE BATCH NUMBER USED WAS NOT PROVIDED. THE PATIENT REPORTED THAT THE FIRST SESSION WAS IN (B)(6) 2012. ON (B)(6) 2012, THE PATIENT EXPERIENCED A SWOLLEN FACE AND NOTICED LUMPS. THE PATIENT HAD LUMPS IN ALL THE AREA OF INJECTION, BUT THE LARGEST LUMP WAS ON THE CHIN. THE LUMP WAS OVER AN INCH LONG AND WAS NOT RED OR HOT. THE PATIENT COULD FEEL AND SEE MANY LUMPS. THE PATIENT REPORTED THAT THERE WERE APPROXIMATELY 15 PATIENT REPORTED THAT THERE WERE APPROXIMATELY 15 RAISED LUMPS BUT INITIALLY THERE WERE 6 BUMPS WHICH LATER WENT UP TO 11 AND HAD LOST IT'S SHAPE. THE PATIENT'S FACE WAS DISTORTED AND HAD SWELLING. IT WAS REPORTED THAT THE PATIENT THOUGHT THE PHYSICIAN "OVER DID IT" OR OVER FILLED AND MAY HAVE BEEN ALLERGIC TO THIS. THE PATIENT WENT BACK TO THE PHYSICIAN WHO INJECTED THE POLY-L-LACTIC ACID AND THE PHYSICIAN RECOMMENDED SALINE INJECTIONS. THE PATIENT SOUGHT A SECOND OPINION AND DIDN'T ACTUALLY SEE THE SECOND DOCTOR, BUT SPOKE WITH A NURSE THERE WHO WAS THE DOCTOR'S WIFE, AND THE NURSE SAID THAT SALINE WAS A TEMPORARY FIX AND WOULD NOT WORK. THE PATIENT WAS GOING TO SEE A DERMATOLOGIST FOR ANOTHER OPINION AND WENT TO A "SCULPTRA EXPERT" ON (B)(6) 2012, WHO TREATED WITH 5-FLUOROURACIL (5-FU) INJECTIONS. NO LABORATORY TESTS WERE PERFORMED. AT THE TIME OF REPORT, THE OUTCOME OF THE EVENTS WAS NOT RECOVERED. THE PATIENT REMARKED THAT THE PRODUCT AND WHAT HAD HAPPENED WAS UNACCEPTABLE. FOR ZOLPIDEM TARTRATE (AMBIEN), ASSOCIATED CASE WITH (B)(4) HAS BEEN CREATED FOR THIS PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2013, TREATMENT DATES OF THE POLY-L-LACTIC ACID, FURTHER DETAILS REGARDING THE EVENTS, ONSET DATE OF THE EVENTS, CORRECTIVE TREATMENT, OUTCOME OF THE EVENTS, MEDICAL HISTORY AND CONCOMITANT MEDICATIONS. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83500 SCULPTRA NONE LMH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R ZOLPIDEM (CON.) UNKNOWN - UNKNOWN| PREV MEDS = UNK