BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL BOWEL 2 CAPSULE

    MDR report key: 4927994 · Received July 17, 2015

    Report

    Report Number
    9710107-2015-00199
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 17, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURE REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    SMALL BOWEL CAPSULE WAS RETAINED IN JEJUNUM. PHYSICIAN DECIDED TO PURSUE FLUOROSCOPY ASSISTED ENTEROSCOPY TO RETRIEVE THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464797 SMALL BOWEL 2 CAPSULE SMALL BOWEL 2 CAPSULE NEZ GIVEN IMAGING LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention