BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLCAM SB 2 CAPSULE

    MDR report key: 4921014 · Received July 15, 2015

    Report

    Report Number
    9710107-2015-00198
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K101250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SMALL BOWEL CAPSULE WAS RETAINED AND FOUR LITERS OF PEG WAS ADMINISTERED TO STIMULATE CAPSULE EXCRETION. THE PATIENT PASSED THE CAPSULE WITHOUT FURTHER ISSUES OR TREATMENTS.

    Description of Event or Problem · 1

    SMALL BOWEL CAPSULE WAS RETAINED AND FOUR LITERS OF PEG WAS ADMINISTERED TO STIMULATE CAPSULE EXCRETION. THE PATIENT PASSED THE CAPSULE WITHOUT FURTHER ISSUES OR TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460583 PILLCAM SB 2 CAPSULE SMALL BOWEL CAPSULE NEZ GIVEN IMAGING LTD. FGS-0179

    Patients

    Seq Age Sex Outcome Treatment
    1