BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 3836073 · Received April 24, 2014

    Report

    Report Number
    9710107-2014-00069
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 24, 2014
    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

    Description of Event or Problem · 1

    CASE STUDY OF ENDOSCOPIC CAPSULE IMPACTION CAUSING ACUTE SMALL INTESTINAL OBSTRUCTION IN A PATIENT WITH CROHN'S DISEASE (CD), HAVING OBSCURE GASTROINTESTINAL BLEEDING. A (B)(6)YEAR OLD FEMALE PRESENTED WITH FEATURES OF ACUTE SMALL BOWEL OBSTRUCTION 2 DAYS AFTER CAPSULE ENDOSCOPY ELSEWHERE FOR THE EVALUATION OF INTERMITTENT BLEEDING PER RECTUM AND IRON DEFICIENCY ANEMIA. PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH RIGHT HEMICOLECTOMY FOR THE DISEASED ILEOCECAL REGION WHICH MIMICKED MALIGNANCY. THE CAPSULE WAS FOUND TO BE IMPACTED IN THE STRICTURED LUMEN OF THE TERMINAL ILEUM. POST-OPERATIVE HISTOPATHOLOGICAL EXAMINATION REVEALED IT TO BE CROHN'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247835 PILLCAM SB2 CAPSULE PILLCAM SB2 CAPSULE NEZ GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention