BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2783348 · Received October 2, 2012

    Report

    Report Number
    9710107-2012-01589
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    November 9, 2012
    Report Date
    February 10, 2012
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K070475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IN THIS CASE EVIDENTLY ASPIRATED THE PILLCAM CAPSULE AFTER ATTEMPTING TO SWALLOW IT. THE CAPSULE WAS SEEN TO BE IN THE PT'S LUNGS ON X-RAY. IT WAS RETRIEVED SUCCESSFULLY BY A PULMONOLOGIST WITH A BRONCHOSCOPE AND SNARE. AS A RESULT, IT APPEARS THAT THIS PT HAS A SWALLOWING DISORDER WHICH LED TO ASPIRATION.

    Description of Event or Problem · 1

    COMPLAINTS OF DIFFICULT BREATHING BY AN ELDERLY WOMAN FOLLOWING AN SB2 PROCEDURE. THE PT HAD XRAY THE FOLLOWING DAY AND IT WAS DETERMINED THAT THE CAPSULE WAS IN HER LUNGS. THE EVENT WAS ACUTE, AN OFFICE PULMONOLOGIST WAS CONSULTED AND REMOVED THE PILLCAM CAPSULE WITH A BRONCHOSCOPE AND SNARE. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB2 CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R