BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCULPTRA

    MDR report key: 1193543 · Received October 9, 2008

    Report

    Report Number
    3002807108-2008-00031
    Event Type
    Other
    Date Received
    October 9, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE HAS BEEN TRUNCATED: INITIAL AND FOLLOW UP INFO RECEIVED FROM AN MD TO A SALES REP ON 11-SEP-08, 15-SEP-2008 AND 16-SEP-2008: A FEMALE PT WAS RECEIVING POLY-L-LACTIC ACID (SCULPTRA) (LOT#S AND EXPIRATION DATES UNK), WITH A TOTAL OF 3 INJ, 1 EACH APPROX THREE MONTHS PRIOR, THE FOLLOWING MONTH, A MONTH LATER (2 VIALS EACH VISIT TOTAL OF 6 VIALS), INDICATION NOT PROVIDED. MEDICAL HISTORY INCLUDED LEFT-SIDED BELL'S PALSY. CON MEDS NOT PROVIDED. THE MD CALLED TO ASK IF THERE WERE ANY EXAMPLES OR CASES REPORTED OF PTS EXPERIENCING WEAKNESS OR PALSY, SPECIFIED ON FOLLOW-UP AS FACIAL WEAKNESS, AFTER INJ OF SCULPTRA. ONSET OF EVENT PROVIDED AS STARTING 3 WKS PRIOR TO THE ORIGINAL MONTH CALL. THE PT HAD A PREVIOUS HISTORY OF LEFT-SIDED BELL'S PALSY (NOS) PRIOR TO TX WITH SCULPTRA. THE PT HAD UPPER EYELID SURGERY TO RESTORE THE SYMMETRY IN HER EYES PRIOR TO SCULPTRA TX. THE REPORTING MD NOTED THAT HE DID NOT PERFORM THE SURGERY, AND IT WAS OVER 1 YEAR AGO. THE MD REPORTED THAT THE PT HAS SOME WEAKNESS ON THE LEFT SIDE IN THE ZYGOMATIC AREA, AND SHE IS UNABLE TO SEE HER TEETH WHEN SHE SMILES; BUT, BECAUSE OF HER HISTORY, THE MD DOES NOT FEEL THAT IT WAS RELATED TO THE SCULPTRA; HOWEVER, AS STATED IN HIS ORIGINAL CALL, HE IS TRYING TO RULE IT OUT. TREATMENT WITH SCULPTRA DOES NOT CONTINUE. NO FURTHER MEDICAL INFORMATION REPORTED. ADDITIONAL INFO FOR SCULPTRA (LOT # AND EXP DATE UNK) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE DATED 02-OCT-08: BBR WAS WITHOUT HINT TO ROOT CAUSE. AN INVESTIGATION HAS BEEN PREFORMED ON THE DOCUMENTATION OF ALL POTENTIALLY INVOLVED MANUFACTURED BATCHES. THE REVIEW OF THE DEVICE HISTORY REPORT AND OF THE ANALYTICAL RESULTS OF THESE BATCHES DID NOT SHOW ANY ANOMALY. THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT IS NOT BATCH RELATED. CONCLUSION: NO FAULTS DETECTABLE.

    Description of Event or Problem · 1

    INITIAL AND ADDITIONAL INFORMATION RECEIVED FROM A PHYSICIAN TO A SALES REPRESENTATIVE ON 11-SEP-2008, WITH ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN ON 15-SEP-2008, AND THE SAME MONTH: A FEMALE PT WAS RECEIVING POLY-L-LACTIC ACID (SCULPTRA) (LOT#S AND EXPIRATION DATES UNK), WITH A TOTAL OF 3 INJECTIONS, 1 EACH APPROX FOUR MONTHS PRIOR, THE FOLLOWING MONTH, A MONTH LATER (2 VIALS EACH VISIT TOTAL OF 6 VIALS), INDICATION NO PROVIDED. THERE WAS NO PREVIOUS EXPOSURE TO THE PRODUCT. MEDICAL HISTORY INCLUDED LEFT- SIDED BELL'S PALSY. CONCOMITANT MEDICATIONS NOT PROVIDED. THE PHYSICIAN CALLED TO ASK IF THERE WERE ANY EXAMPLES OR CASES REPORTED OF PTS EXPERIENCING WEAKNESS OR PALSY, SPECIFIED ON FOLLOW-UP AS FACIAL WEAKNESS, AFTER INJECTIONS OF POLY-L-LACTIC ACID. HE REPORTED THAT HE HAS A PT THAT DID EXPERIENCE THIS. ONSET OF EVENT PROVIDED AS STARTING 3 WEEKS PRIOR TO THE ORIGINAL MONTH CALL. THE PT HAD A PREVIOUS HISTORY OF LEFT-SIDED BELL'S PALSY, (DATE NOT SPECIFIED), PRIOR TO TREATMENTS WITH POLY-L-LACTIC ACID. ALSO PRIOR TO THE TREATMENT WITH POLY-L-LACTIC ACID, THE PT HAD UPPER EYELID SURGERY TO RESTORE THE SYMMETRY IN HER EYES. THE REPORTING PHYSICIAN NOTED THAT HE DID NOT PERFORM THE SURGERY, AND IT WAS OVER 1 YEAR AGO. THE PHYSICIAN REPORTED THAT SHE RECEIVED 3 POLY-L-LACTIC ACID INJECTIONS, "AND HAD SOME DECREASE IN THE LEFT SIDE." ON FOLLOW-UP CALL, THE PHYSICIAN REPORTED THAT THE PT HAS SOME WEAKNESS ON THE LEFT SIDE IN THE ZYGOMATIC AREA, AND SHE IS UNABLE TO SEE HER TEETH WHEN SHE SMILES; BUT, BECAUSE OF HER HISTORY, THE PHYSICIAN DOES NOT FEEL THAT IT WAS RELATED TO THE POLY-L-LACTIC ACID; HOWEVER, AS STATED IN HIS ORIGINAL CALL, HE IS TRYING TO RULE IT OUT. HE STATED THAT HE FEELS THAT SHE WILL IMPROVE IN THE NEXT FEW WEEKS. TREATMENT WITH POLY-L-LACTIC ACID DOES NOT CONTINUE. NO FURTHER MEDICAL INFORMATION REPORTED. ADDITIONAL INFORMATION FOR SCULPTRA (LOT # AND EXPIRATION DATE - NOT PROVIDED) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE DATES 02-OCT-2008, RECEIVED ON 03-OCT-2008: BATCH RECORD REVIEW WAS WITHOUT HINT TO ROOT CAUSE. BECAUSE NO LOT NUMBER IS AVAILABLE, AN INVESTIGATION HAS BEEN PERFORMED ON THE DOCUMENTATION OF ALL POTENTIALLY INVOLVED MALFUNCTIONED BATCHES MARKETED IN THE USA. THE REVIEW OF THE DEVICE HISTORY REPORTS AND OF THE ANALYTICAL RESULTS OF THESE BATCHES DID NOT SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT WHICH OCCURRED. THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT IS NOT BATCH RELATED. NO FAULTS, DEFECTS OR DAMAGES DETECTABLE. CONCLUSION: NO FAULTS DETECTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA INJECTABLE LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR