BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCULPTRA

    MDR report key: 1392458 · Received May 21, 2009

    Report

    Report Number
    3002807108-2009-00018
    Event Type
    Other
    Date Received
    May 21, 2009
    Report Date
    February 1, 2009
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    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 MANUFACTURED BATCHES. THE REVIEW OF THE DEVICE HISTORY REPORT 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. BATCH RECORD REVIEW WAS WITHOUT HINT TO ROOT CAUSE. NO LOT NUMBER; AN INVESTIGATION PERFORMED ON ALL POTENTIALLY INVOLVED MANUFACTURED BATCHES. REVIEW OF THE DEVICE HISTORY REPORT AND ANALYTICAL RESULTS OF THESE BATCHES DID NOT SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT. INVESTIGATION SHOW THAT THIS KIND OF EVENT IS NOT BATCH RELATED. NO FAULTS, DEFECTS OR DAMAGES DETECTABLE.

    Description of Event or Problem · 1

    (B)(4). INITIAL INFO RECEIVED FROM A NURSE REPORTING FOR HERSELF VIA SALES REPRESENTATIVE ON 01-FEB-2009: A (B)(6) FEMALE NURSE INITIATED THERAPY WITH POLY-L-LACTIC ACID (SCULPTRA) (LOT# AND EXPIRATION DATE UNK), THREE MONTHS AGO. SHE FELT HER PHYSICIAN INJECTED OVERDOSE OF SCULPTRA. SHE EXPERIENCED OVER GROWTH AROUND HER EYE, INSIDE HER NOSE, WHICH WAS LOOKED LIKE AN INSECT BITE IN THE AREA, AFTER FIRST SESSION. HER RIGHT SIDE WAS SWOLLEN AND SHE HAD BEEN BLACK AND BLUE FOR A MONTH. SHE USED TRIAMCINOLONE ACETONIDE (KENALOG) FOR TREATMENT OF HER EVENT, BUT IT DID NOT HELP BECAUSE SHE HAD OVER GROWTH. THE EVENT WAS ONGOING AT THE TIME OF THIS REPORT. SHE ALSO HAS USED MULTIPLE OTHER PRODUCTS IN COINJECTION AROUND HER EYES. THERE WERE NO CONCOMITANT MEDICATIONS AND MEDICAL HISTORY REPORTED. NO FURTHER RELEVANT INFO REPORT. ADDITIONAL INFO RECEIVED FROM A PROFESSIONAL LAW PRACTICE VIA THE LEGAL DEPARTMENT ON 14-MAY-2009. BASED ON THE ADDITIONAL INFO RECEIVED, THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS: THE PT RECEIVED POLY-L-LACTIC INJECTIONS ON (B)(6) 2008 (PREVIOUSLY REPORTED AS (B)(6) 2008), FOR COSMETIC PURPOSES ONLY. IMMEDIATELY AFTER THE INJECTION, THE PT FELT DISCOMFORT AND SWELLING THAT INCREASED IN SIZE AND TENDERNESS. FOR ALMOST 5 WEEKS THE PT HAD CONSTANT IRRITATION BURNING AND OBSTRUCTED VISION BECAUSE OF THE POLY-L-LACTIC INJECTION BELOW HER RIGHT EYE. THE PT SPENT THE NEXT SIX MONTHS AFTER THE INJECTION GOING FROM DOCTOR TO DOCTOR HOPING TO FIND A PHYSICIAN ABLE TO EITHER SURGICALLY OR CHEMICALLY STOP THE TISSUE GROWTH INSTIGATED BY THE POLY-L-LACTIC INJECTION, HOWEVER, THERE WAS NOTHING ANY PHYSICIAN COULD DO BECAUSE, OVER A MONTH HAD ELAPSED. AS THE WEEKS TURNED INTO MONTHS, THE PT SUFFERED FROM NEVER-ENDING BURNING SENSATION IN HER EYE AND PERMANENTLY OBSTRUCTED VISION IN HER RIGHT EYE. SHE WAS TOLD BY A PHYSICIAN THAT THE DAMAGE WOULD NOT BE ABLE TO BE REPAIRED DUE TO THE PERMANENT NATURE OF TISSUE GROWTH. SHE WAS ALSO TOLD DUE TO THE LUMP BELOW HER EYE, SHE IS NOT ALLOWED TO HAVE SODIUM (SALT) OR ALCOHOL. THE PT BECAME DEVASTATED FROM THE WAY SHE LOOKED AND THE COMMENTS SHE HAD BEEN GETTING FROM HER FRIENDS. ON (B)(6) 2009, THE PT UNDERWENT AN MRI OF HER FACIAL REGION, WHICH REVEALED "MILD PROMINENCE OF THE SUBCUTANEOUS SOFT TISSUES INFERIOR TO THE RIGHT ORBIT AND THIS IS PROBABLY RELATED TO THE PT'S COSMETIC SURGERY IN THIS REGION. NO FLUID COLLECTIONS. "ACCORDING TO THE ORDERING PHYSICIAN OF THE MRI, THE POLY-L-LACTIC ACID HAD BEEN INJECTED ON TOP OF THE MUSCLE, WHICH THEN CAUSED A LARGE LUMP TO FORM AND CAUSED GROWING TISSUE. THIS PHYSICIAN FELT THE DAMAGE WOULD HAVE BEEN LESS IF THE INJECTION WAS INJECTED CORRECTLY (BELOW THE MUSCLE). THE PT TOOK A TRIP TO ISRAEL AND ON (B)(6) 2009, A PHYSICIAN THERE EXAMINED HER. ON EXAMINATION, THERE WAS LOWER LID SWELLING AFFECTING THE LATERAL SOOF (SUBORBICULARIS OCULI FAT) IN THE RIGHT SIDE ONLY, MODERATE DERMATOCHALASIS AND RIGHT MEDIAL PREAPONEUROTIC FAT PROLAPSE, BILATERAL LOW BROW PTOSIS AND BILATERAL CANTHAL TENDON MODERATE PROLAPSE. THE PHYSICIAN PERFORMED AN UPPER BLEPHAROPLASTY WITH LATERAL BROW LIFT AND LATERAL CANTHAL RECONSTRUCTION. DUE TO THE FILLER INJECTED INTO THE LOWER LID, IT WAS NOT ADVISABLE TO PERFORM SURGERY ON THE LOWER LIDS. SHE WAS SENT HOME AFTER SURGERY AND WAS PRESCRIBED A STEROID CREAM TO BE USED ONCE DAILY FOR 2 WEEKS. THIS PROVIDED MINIMAL IMPROVEMENT TO HER APPEARANCE, BUT DID NOTHING TO STOP THE CONTINUED SWELLING, BURNING, IRRITATION AND VISUAL OBSTRUCTION. THE REPORTER STATED THAT AT THE TIME OF THE REPORT, THE PT WAS DISFIGURED, LOST PARTIAL VISION IN HER RIGHT EYE, AND CONTINUED TO SUFFER SEVERE PHYSICAL, EMOTIONAL AND MENTAL DISTRESS DUE TO THE OFF-LABEL USE OF SCULPTRA. NO FURTHER RELEVANT INFO REPORTED.

    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 52 YR