BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIVEN IMAGING

    MDR report key: 1802806 · Received August 13, 2010

    Report

    Report Number
    MW5017066
    Event Type
    Death
    Date Received
    August 13, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 9, 2010
    Manufacturer
    GIVEN IMAGING
    Product Code
    NEZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CAPSULE ENDOSCOPY AND PASSED AWAY THE SAME NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIVEN IMAGING SB CAPSULE NEZ GIVEN IMAGING PCSB-2-10-S 2010.02/124608

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death