BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA, POLY-L-LACTIC ACID

    MDR report key: 3581434 · Received January 8, 2014

    Report

    Report Number
    3009443653-2014-00003
    Event Type
    Injury
    Date Received
    January 8, 2014
    Report Date
    December 27, 2013
    Manufacturer
    VALEANT USA
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN'S ASSISTANT AND CONCERNED A FEMALE PT OF UNREPORTED AGE. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, OVER A YEAR PRIOR TO THIS REPORT, THE PT WAS INJECTED WITH SCULPTRA (POLY-L-LACTIC ACID) FOR AN UNK INDICATION. THE BATCH NUMBER USED WAS NOT REPORTED. ON AN UNK DATE, THE PT EXPERIENCED NODULES ALL OVER FACE AND A CUSHING LIKE APPEARANCE. THE OUTCOME OF THE EVENT WAS UNK. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBER:(B)(4)(MEDCOMM SOLUTIONS ON BEHALF OF (B)(4)). A PRODUCT COMPLAINT . REPORT HAS ALSO BEEN FILED (B)(4). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11845 SCULPTRA, POLY-L-LACTIC ACID INJECTABLE DERMAL FILLER LMH VALEANT USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other