BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNERDYNE REGULAR

    MDR report key: 1242143 · Received November 10, 2008

    Report

    Report Number
    1242143
    Event Type
    Death
    Date Received
    November 10, 2008
    Date of Event
    April 24, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THERE WERE NO COMPLICATIONS AFTER SURGERY OR SUBSEQUENTLY, BUT THEN PATIENT DIED A FEW WEEKS LATER FROM SUDDEN ONSET OF "SEPSIS DUE TO PERITONITIS WITH ASCITES DUE TO BETA STREPTOCOCCUS GROUP A WOUND INFECTION," ACCORDING TO THE AUTOPSY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERDYNE REGULAR GASTRIC BAND LTI ALLERGAN, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death OTHER| OTHER