BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 5003523 · Received August 12, 2015

    Report

    Report Number
    9710107-2015-00219
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 29, 2015
    Report Date
    November 18, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT SWALLOWED A PILLCAM CAPSULE WHICH WAS ASPIRATED TO THE LUNGS. THE PATIENT WAS ASYMPTOMATIC. A BRONCHOSCOPY WAS PERFORMED AND THE CAPSULE WAS RETRIEVED. THE PATIENT WAS DISCHARGED THE SAME DAY AND HAS REMAINED ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529104 PILLCAM SB2 CAPSULE SYSTEM IMAGING GASTROINTESTINAL WIRELESS CAPSULE NEZ GIVEN IMAGING LTD. FGS-0179

    Patients

    Seq Age Sex Outcome Treatment
    1