BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM SB2 PLUS CAPSULE

    MDR report key: 5163983 · Received October 21, 2015

    Report

    Report Number
    9710107-2015-00256
    Event Type
    Death
    Date Received
    October 21, 2015
    Date of Event
    September 13, 2015
    Report Date
    October 20, 2015
    Manufacturer
    GIVEN IMAGING LTD
    Product Code
    NEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF DIFFICULTY SWALLOWING, EMACIATION, AND MELENA SWALLOWED BOTH PATENCY AND SMALL BOWEL 2 CAPSULE UNDER ENDOSCOPIC ASSISTANCE. THE CAPSULE EXAMINATION WAS SUCCESSFUL. A FEW MONTHS AFTER CAPSULE EXAMINATION IT WAS REPORTED THAT PATIENT DEVELOPED PNEUMONIA AND WAS HOSPITALIZED. PATIENT EXPIRED FROM ASPIRATION PNEUMONIA. THE PHYSICIAN DETERMINED CAUSE OF DEATH UNRELATED TO CAPSULE EXAMINATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695726 PILLCAM SB2 PLUS CAPSULE SB2 CAPSULE NEZ GIVEN IMAGING LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death