BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL

    MDR report key: 1124383 · Received August 15, 2008

    Report

    Report Number
    MW5007996
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ARTES MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROTOCOL: ARTES 521-01: PROTOCOL FOR THE POST-APPROVAL STUDY OF ARTEFILL FOR CORRECTION OF NASOLABIAL FOLDS. PT WAS ENROLLED IN THE STUDY IN 2008, HAS RECEIVED TREATMENT WITH ARTEFILL AND IS STILL ACTIVE IN THE TRIAL. PT CALLED AND LEFT A MESSAGE ON MY OFFICE PHONE ON 8/6/2008 STATING SHE WAS ADMITTED TO THE HOSPITAL AND HAS BEEN ADMITTED AS AN INPATIENT. I RECEIVED THE MESSAGE THIS MORNING, 8/7/2008 AND IMMEDIATELY CALLED HER BACK. PT EXPLAINED SHE WAS MOVING FURNITURE AT HOME IN 2008 WHEN SHE FELL AND FRACTURED HER PELVIS. EVENT OCCURRED AT 5:40 PM. PT WAS ADMITTED TO HOSPITAL AT 6:15 PM. SHE WEARS AN ABDOMINAL BRACE EIGHT HOURS PER DAY AND RECEIVES PHYSICAL AND OCCUPATIONAL THERAPY TWICE PER DAY AT TWO HOURS EACH THERAPY SESSION. PT WILL BE RELEASED FROM THE HOSPITAL IN APPROXIMATLY ONE WEEK. EVENT IS BEING REPORTED GIVEN IT MEETS THE PROTOCOL DEFINITION OF SERIOUS ADVERSE EVENT (SAE). INVESTIGATOR ASSESSEMENT: THIS EVENT IS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTEFILL ARTEFILL LMH ARTES MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization