BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 2323500 · Received October 31, 2011

    Report

    Report Number
    3002807108-2011-64836
    Event Type
    Injury
    Date Received
    October 31, 2011
    Date of Event
    September 26, 2011
    Report Date
    October 31, 2011
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENTS DATED 27-OCT-2011: THIS CASE IS CONFOUNDED BY THE UNDERLYING MEDICAL HISTORY OF (B) (6) INFECTION. IT IS NOTEWORTHY, THIS PT CONTINUES TO RECEIVE SCULPTRA DESPITE REPORTED REACTION. ADDITIONAL LOT# A1043.

    Description of Event or Problem · 1

    BASED ON INITIAL INFO RECEIVED ON (B)(4) 2011, THE CASE WAS ASSESSED AS NON-SERIOUS. BASED ON ADDITIONAL INFO RECEIVED ON (B)(4) 2011, THE CASE WAS REASSESSED AS SERIOUS DUE TO TREATMENT MEASURES WITH VALACICLOVIR. INITIAL INFO WAS RECEIVED FROM A NURSE VIA A SALES REP ON (B)(4) 2011: A (B)(6) FEMALE RECEIVED 2 VIALS OF POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT #A1041 AND A1043, EXP DATE FEB 2014 AND APR 2014) SUBCUTANEOUSLY INJECTED ON (B)(6) 2011 FOR FACIAL VOLUMIZATION (COSMETIC). EACH VIAL WAS RECONSTITUTED WITH 8 CC STERILE WATER AND 1 CC LIDOCAINE 1%. BENZOCAINE TOPICAL WAS USED TO PREPARE THE PT FOR INJECTION. ONE OF THE VIALS WAS MIXED 2 WEEKS PRIOR TO INJECTION AND THE OTHER VIAL WAS MIXED ONE DAY PRIOR. MASSAGE WAS DONE DURING TREATMENT AND THEN BY THE PT. THE PT WAS SEEN SIX DAYS LATER AND WAS REPORTING PAIN AND SWELLING. THE PT FELT AS IF THERE WERE TWO DIFFERENT SOLUTIONS BEING INJECTED IN HER CHEEKS AND THE PT WAS COMPLETELY UNAWARE THAT THE SOLUTIONS WAS MIXED ON DIFFERENT DAYS. THE NURSE STATED THEY DIDN'T WRITE DOWN WHICH VIAL WAS INJECTED INTO EACH CHEEK. THE DOCTOR THOUGHT THE DISCOMFORT IN THE LIP WAS FROM A COLD SORE. MEDICAL TREATMENT INCLUDED (B)(6). THERE WAS NO SURGICAL INTERVENTION. MEDICAL HISTORY INCLUDED (B)(6) INJECTION AND NO KNOWN DRUG ALLERGIES. THE PT HAD NO KNOWN DRUG ALLERGIES. THE SALES REP STATED HIS INTERPRETATION WAS THE POLY-L-LACTIC ACID WAS NOT INJECTED INTO THE PT'S LIP AND THAT THE PAIN AND DISCOMFORT IN HER LIP WERE COMING FROM THE COLD SORE. THERE WAS NO EVIDENCE OF A SYSTEMIC PROCESS WHICH DEVELOPED AFTER THE INJECTION. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENTS WAS RECOVERED AND THERAPY WITH SCULPTRA WAS CONTINUING. CONCOMITANT MEDICATIONS INCLUDED ERGOCALCIFEROL [VITAMIN D], ESTROGENS CONJUGATED/ MEDROXYPROGESTERONE ACETATE [PREMPRO], ASCORBIC ACID [VITAMIN C], ALENDRONATE SODIUM [FOSAMAX], AND (B)(6). NO FURTHER RELEVANT INFO REPORTED. ADDITIONAL INFO WAS RECEIVED FROM THE NURSE ON (B)(6) 2011: AGE, OUTCOME, TREATMENT (UPGRADED CASE TO SERIOUS), INDICATION, LOT, EXP DATE, CONCOMITANT MEDICATIONS, MEDICAL HISTORY PROVIDED. NARRATIVE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH AVENTIS PHARMA GRUPPO LEPETIT S.R.L. A1041

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other FOSAMAX (CON.)| PREMPRO (CON.)| LIDOCAINE (CON.)| VITAMIN C (CON.)| (B)(6) (CON.)| PREV MEDS =UNK| VITAMIN D (CON.)| BENZOCAINE (CON>)