BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA, POLY-L-LACTIC ACID

    MDR report key: 4091245 · Received June 27, 2014

    Report

    Report Number
    3009443653-2014-00136
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    December 1, 2012
    Report Date
    March 6, 2014
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: ON 06-MAR-2014. EVENTS MUSCULAR WEAKNESS, BLADDER DISORDER AND DYSPNOEA WERE ADDRESSED AS SERIOUS AND POSSIBLY RELATED. EVENTS VISION BLURRED, DYSARTHRIA AND DYSPHAGIA WERE ASSESSED AS NON SERIOUS AND POSSIBLY RELATED. LACK OF DETAILED INFO REGARDING MEDICAL HISTORY, LAB DATA AND CONCOMITANT DRUGS PRECLUDES THE DEFINITIVE ASSESSMENT OF THE CASE.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT SENT TO VALEANT BY ANOTHER MANUFACTURER (B)(4) ON 06-MAR-2014 AND CONCERNED A (B)(6) YEAR OLD FEMALE PT. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT INCLUDED. IN (B)(6) 2012, THE PT STARTED TREATMENT WITH SCULPTRA (POLY-L-LACTIC ACID) AT AN UNK DOSE TO HER TEMPLES AND JAW FOR WRINKLES. THE BATCH NUMBER AND EXPIRY DATE USED WAS REPORTED. ON (B)(6) 2012, THE PT EXPERIENCED MUSCLE AND STRENGTH WEAKNESS ALL OVER HER BODY, BLURRED VISION, PROBLEMS WITH HER BLADDER, DIFFICULTY SPEAKING AND BREATHING, AND DIFFICULTY SWALLOWING. THE OUTCOME OF THE EVENTS WAS NOT REPORTED. NO INFO ABOUT MEDICAL EVAL OR CAUSALITY ASSESSMENT WAS PROVIDED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377271 SCULPTRA, POLY-L-LACTIC ACID NONE LMH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other