BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCULPTRA

    MDR report key: 862181 · Received June 7, 2007

    Report

    Report Number
    3002807108-2007-00012
    Event Type
    Other
    Date Received
    June 7, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 22, 2007
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY / SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT RECEIVED FROM AN INFECTIOUS DISEASE PHYSICIAN IN 2007: THIS SPONTANEOUS CASE INVOLVES A FEMALE PT (AGE UNSPECIFIED) WHO WAS TREATED WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA) ON AN UNSPECIFIED DATE, "ABOUT 2 WEEKS AGO". MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PHYSICIAN REPORTED THAT A PODIATRIST INJECTED POLY-L-LACTIC ACID INTO THE PLANTAR SURFACE OF THE PT'S FOOT BECAUSE THE PT WANTED TO FEEL MORE COMFORTABLE WHEN SHE PLAYED TENNIS. THE PODIATRIST FELT THAT HE COULD PROVIDE EXTRA CUSHION USING POLY-L-LACTIC ACID. ONE WEEK AFTER TREATMENT, THE PT DEVELOPED AN ABSCESS IN ONE OF THE FEET WITH A STAPHYLOCOCCUS AUREUS INFECTION. SHE WAS HOSPITALIZED OVERNIGHT, TREATED WITH ANTIBIOTICS (NOS), AND HAD HER FOOT DRAINED. DURING THE DRAINAGE, FLUID AND SOME OF THE POLY-L-LACTIC ACID MATERIAL WERE REMOVED. BLOOD CULTURES WERE NEGATIVE. IT WAS REPORTED THAT THE PT'S FOOT WOUND IS NOW OPEN AND THAT SHE IS RECOVERING. THE REPORTER ASSESSED THE EVENT AS AN IATROGENIC INFECTION, MOST LIKELY FROM THE PODIATRIST'S OFFICE, AS OPPOSED TO BEING RELATED TO POLY-L-LACTIC ACID ITSELF. LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. NO FURTHER INFO WAS PROVIDED.

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED FROM AN INFECTIOUS DISEASE PHYSICIAN IN 2007: THIS SPONTANEOUS CASE INVOLVES A FEMALE PT (AGE UNSPECIFIED) WHO WAS TREATED WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA) ON AN UNSPECIFIED DATE "ABOUT 2 WEEKS AGO". MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PHYSICIAN REPORTED THAT A PODIATRIST INJECTED POLY-L-LACTIC ACID INTO THE PLANTAR SURFACE OF THE PT'S FOOT BECAUSE THE PT WANTED TO FEEL MORE COMFORTABLE WHEN SHE PLAYED TENNIS. THE PODIATRIST FELT THAT HE COULD PROVIDE EXTRA CUSHION USING POLY-L-LACTIC ACID. ONE WEEK AFTER TREATMENT, THE PT DEVELOPED AN ABSCESS IN ONE OF THE FEET WITH A STAPHYLOCOCCAL AUREUS INFECTION. SHE WAS HOSPITALIZED OVERNIGHT, TREATED WITH ANTIBIOTICS, AND HAD HER FOOT DRAINED. DURING THE DRAINAGE, FLUID AND SOME OF THE POLY-L-LACTIC ACID MATERIAL WERE REMOVED. BLOOD CULTURES WERE NEGATIVE. IT WAS REPORTED THAT THE PATIENT'S FOOT WOUND IS NOW OPEN AND THAT SHE IS RECOVERING. THE REPORTER ASSESSED THE EVENT AS AN IATROGENIC INFECTION, MOST LIKELY FROM THE PODIATRIST'S OFFICE, AS OPPOSED TO BEING RELATED TO POLY-L-LACTIC ACID ITSELF. LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    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 YR