BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 4092441 · Received September 4, 2014

    Report

    Report Number
    3009443653-2014-00322
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    August 11, 2014
    Manufacturer
    VALEANT USA
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2014 FROM A CONSUMER AND CONCERNED A FEMALE PT OF AN UNREPORTED AGE. THE PT'S MED HISTORY AND WAS NOT REPORTED. ON AN UNK DATE, THE PT STARTED TREATMENT WITH SCULPTRA, IN THE FORM OF POLY-L-LACTIC ACID INJECTION, ADMINISTERED INTO THE ROOF OF THE MOUTH (TO TREAT HOLLOW EYES). IT WAS REPORTED THAT PT WAS ALSO ADMINISTERED WITH "PGP." THE BATCH NUMBER USED WAS NOT REPORTED. ON AN UNK DATE, APPROXIMATELY THREE WEEKS PRIOR TO REPORT, THE PT WAS HOSPITALIZED FOR SURGICAL REMOVAL AFTER THE SCULPTRA BECAME LUMPY. THE OUTCOME OF THE EVENT WAS UNK. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. THIS CASE WAS FORWARDED TO VALEANT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541640 SCULPTRA INJECTABLE DERMAL FILLER LMH VALEANT USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R