BEUDAMED
    FDA Adverse Event Other Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 3187976 · Received June 21, 2013

    Report

    Report Number
    9710107-2013-00137
    Event Type
    Other
    Date Received
    June 21, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K101250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN IMAGING LABELING, SUCH AS USER MANUAL INDICATE THAT PILLCAM SB CAPSULES ARE CONTRA-INDICATED FOR USE IN SOME PATIENTS. ALTHOUGH THE PATIENTS HAD NO KNOWN HISTORY OF SWALLOWING PROBLEMS AND THE CAPSULE INGESTION WAS UNEVENTFUL, ONE MAY SUSPECT, HOWEVER, THAT THE PATIENT DOES INDEED HAVE A SWALLOWING PROBLEM IF HE DID ASPIRATE THE CAPSULE. SWALLOWING DISORDER IS A RECOGNIZED CONTRA-INDICATION TO THE USE OF CAPSULE ENDOSCOPY.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT PILLCAM CAPSULE ENDOSCOPY PER NORMAL PROTOCOL WITHOUT ANY INCIDENT. THE PHYSICIAN WHO READ THE PILLCAM STUDY STATED THAT IT WAS AN INCOMPLETE STUDY AND THE CAPSULE DID NOT LEAVE THE STOMACH. FOUR MONTH LATER FOLLOWING PATIENT'S COMPLAINTS OF SHORTNESS OF BREATH, IT WAS REVEALED IN AN X-RAY THAT THE CAPSULE APPEARED TO BE IN THE PATIENT'S LUNGS. THE CAPSULE WAS RETRIEVED BY BRONCHOSCOPY AND THE PATIENT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282317 PILLCAM SB2 CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention