BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA, POLY-L-LACTIC ACID

    MDR report key: 3190827 · Received June 25, 2013

    Report

    Report Number
    3009443653-2013-00128
    Event Type
    Injury
    Date Received
    June 25, 2013
    Report Date
    June 17, 2013
    Manufacturer
    VALEANT USA
    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: (B)(4) 2013. THE EVENTS NODULES, PAPULES, GRANULOMAS, OFF LABEL USE, DISFIGUREMENT, SEVERE PHYSICAL PAIN, MENTAL SHOCK, AND UNABLE TO PURSUE USUAL DAILY DUTIES AND VOCATION, ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS LEGAL CASE WAS RECEIVED ON (B)(4) 2013 FROM A LAWYER VIA PARTNER SANOFI. THIS REPORT REFERS TO A FEMALE PT WITH AN UNKNOWN AGE. THERE WAS NO INFORMATION OF ANY MEDICAL HISTORY FOR THIS PT. ON (B)(6) 2007, THE PT WAS INJECTED WITH SCULPTRA (POLY-L-LACTIC ACID). IT WAS REPORTED THAT THE PT WAS UNABLE TO PURSUE USUAL DAILY DUTIES AND VOCATION. REPORTER STATED THAT THE PT EXPERIENCED NODULES, PAPULES, GRANULOMAS OR SKIN REACTIONS. IT WAS REPORTED THAT THE PHYSICIAN USE SCULPTRA OFF LABEL, DESPITE KNOWING IT WAS A DANGEROUS AND HAD A MULTITUDE OF KNOWN SIDE-EFFECTS. AS A RESULT OF THE INJECTION OF 'SCULPTRA" PT SUFFERED DISFIGUREMENT, SEVERE PHYSICAL PAIN AND MENTAL ANGUISH, ALL OF WHICH ARE OF A PERMANENT NATURE. THE PT HAD SUSTAINED SERIOUS TEMPORARY AND PERMANENT INJURIES AND SUFFERED SEVERE MENTAL SHOCK. THE PT HAS BEEN COMPELLED TO SECURE MEDICAL AID AND MEDICINES IN AN EFFORT TO CURE OR MINIMIZE HIS INJURIES, AND WOULD REQUIRE FURTHER MEDICAL AID AND ASSISTANCE FOR AN INDEFINITE PERIOD OF TIME, ALL TO HIS SUBSTANTIAL DAMAGE. REPORTER STATED THAT SCULPTRA WAS LETHAL, TOXIC, DAMAGING AND NOT FIT FOR HUMAN USE WITHOUT CAUSING SEVERE HARM AND INJURY, AND WAS NOT OF A MERCHANTABLE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288462 SCULPTRA, POLY-L-LACTIC ACID FACIAL IMPLANT LMH VALEANT USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other