BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2062621 · Received April 7, 2011

    Report

    Report Number
    9710107-2011-00260
    Event Type
    Injury
    Date Received
    April 7, 2011
    Report Date
    April 7, 2011
    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 AIRWAY ON THE VIDEO. A SUBSEQUENT BRONCHOSCOPY CONFIRMED THAT THE CAPSULE WAS IN THE LUNG AND IT WAS RETRIEVED SUCCESSFULLY WITHOUT ADVERSE EVENT. THE PT WAS ASYMPTOMATIC THROUGHOUT THIS EPISODE. AS A RESULT, IT APPEARS THAT THIS PT HAS A SWALLOWING DISORDER WHICH LED TO ASPIRATION.

    Description of Event or Problem · 1

    (B)(4). THE PT HAS A BRONCHOSCOPE TO RETRIEVE THE CAPSULE. PT WAS MALE, (B)(6) YEARS OLD. PROCEDURE DATE - (B)(6) 2011, BRONCHOSCOPY DATE - (B)(6) 2011 PT DID NOT REALIZED THE CAPSULE WAS IN HIS LUNG UNTIL THE DOCTOR CALLED HIM AFTER READING THE PILLCAM STUDY AND ASKED HIM TO COME BACK IN. THE CAPSULE WAS IN THE PT'S LUNG FOR 48 HRS BEFORE REMOVAL BY BRONCHOSCOPE. THE PT IS OK - NO ADVERSE ADVENTS WHILST THE CAPSULE WAS IN HIS LUNG OR POST REMOVAL.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R