BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA, POLY-L-LACTRIC ACID

    MDR report key: 3083993 · Received April 19, 2013

    Report

    Report Number
    3009443653-2013-00012
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    August 5, 2012
    Report Date
    January 29, 2013
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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)(6) 2012 FROM A CONSUMER VIA SANOFI )PARTNER COMPANY) AND CONCERNED A (B)(6) FEMALE PATIENT. THE PT'S MEDICAL HISTORY WAS NOT REPORTED. THE CONCOMITANT MEDICATION OF PT INCLUDED ZOLPIDEM (AMBIEN) FOR OCCASIONAL INSOMNIA. FROM (B)(6) 2012 (FIRST SESSION) TO (B)(6) 2012 (LAST SESSION) THE PT 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 PT REPORTED THAT THE FIRST SESSION WAS IN (B)(6) 2012. ON (B)(6) 2012, THE PT EXPERIENCED A SWOLLEN FACE AND NOTICED LUMPS. THE PT HAD LUMPS IN ALL THE AREAS OF INJECTION, BUT THE LARGEST LUMP WAS ON THE CHIN. THE LUMP WAS OVER AN INCH LONG AND WAS NOT RED OR HOT. THE PT COULD FEEL AND SEE MANY LUMPS. THE PT REPORTED THAT THERE WERE APPROXIMATELY 15 RAISED LUMPS BUT INITIALLY THERE WERE 6 BUMPS WHICH LATER WENT UP TO 11 AND HAD LOST ITS SHAPE. THE PT'S FACE WAS DISTORTED AND HAD SWELLING. IT WAS REPORTED THAT THE PT THOUGHT THE PHYSICIAN "OVER DID IT" OR OVER FILLED AND MAY HAVE BEEN ALLERGIC TO THIS. THE PT WENT BACK TO THE PHYSICIAN WHO INJECTED THE POLY-L-LACTIC ACID AND THE PHYSICIAN RECOMMENDED SALINE INJECTIONS. THE PT 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 PT WAS GOING TO SEE A DERMATOLOGIST FOR ANOTHER OPINION AND WENT TO A "SCULPTRA EXPERT" ON (B)(6) 2012, WHO TREATED WITH 5-FLUOUOURACIL (5-FU) INJECTIONS. NO LABORATORY TESTS WERE PERFORMED. AT THE TIME OF REPORT, THE OUTCOME OF THE EVENTS WAS NOT RECOVERED. THE PT REMARKED THAT THE PRODUCT AND WHAT HAD HAPPENED WAS UNACCEPTABLE. FOR ZOLPIDEM TARTRATE (AMBIEN), ASSOCIATED CASE WITH SIEBEL ID (B)(4) HAS BEEN CREATED FOR THIS PT. ADDITIONAL INFO FOR SCULPTRA AESTHETIC (LOT # UNK AND EXPERIENCED DATE: UNK) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE ID (B)(4) DATE (B)(6) 2012, RECEIVED BY USPV 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 BATCH NUMBER WAS COMMUNICATED, THE DOCUMENTATION RELEVANT TO ALL THE SCULPTRA BATCHES MARKETED IN UNITED STATES AND NOT YET EXPIRED WAS RECONTROLLED. FOR EACH BATCH, BOTH SEMI-FINISHED AND FINISHED (PACKAGING) DOCUMENTATION HAVE BEEN RE-CHECKED 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. ADDITIONAL INFO WAS RECEIVED FROM THE PT ON (B)(6) 2013, TREATMENT DATES OF THE POLY-L-LACTIC ACID, FURTHER DETAILS REGARDING THE EVENT, 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 INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168937 SCULPTRA, POLY-L-LACTRIC ACID FACIAL IMPLANT LMH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other