BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2151603 · Received June 29, 2011

    Report

    Report Number
    9710107-2011-00527
    Event Type
    Injury
    Date Received
    June 29, 2011
    Report Date
    September 21, 2010
    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

    IT WAS DETERMINED FROM THE PUBLICATION THAT THE CAPSULE WAS INGESTED IN 2003. THE RADIOGRAPH SHOWN IN THE PUBLICATION WAS OBTAINED THREE YEARS AFTER THE CAPSULE ENDOSCOPY AND IS DATED (B)(6) 2006. IT MAY BE INFERRED, CONSEQUENTLY, THAT THE CAPSULE IN THIS CASE REPORT IS NO LONGER IN USE AND IT HAS NOT BEEN MARKETED SINCE 2004. SINCE DESIGN CHANGES WERE IMPLEMENTED, THERE HAVE BEEN NO CONFIRMED REPORTS OF CAPSULE FRAGMENTATION.

    Description of Event or Problem · 1

    (B)(4) PUBLICATION. A (B)(6) YEAR-OLD WOMAN PRESENTED RECURRENT EPISODES OF ABDOMINAL PAIN AND ANEMIA WITH NONCONCLUSIVE ENDOSCOPIC, RADIOLOGICAL, AND SCINTIGRAPHIC EVALUATIONS. SHE RECEIVED STEROIDS, MESALAZINE, METRONIDAZOLE, AND AZATHIOPRINE TO A SUSPECTED DIAGNOSIS OF CROHN'S DISEASE (CD), WITHOUT CLINICAL IMPROVEMENT. THE CAPSULE DID NOT PASS THROUGH THE ILEOCECAL VALVE, BUT AN ABDOMINAL X-RAY WAS NOT PERFORMED AS THE PT DISCONTINUED FOLLOW-UP. AFTER 3 YEARS, THE PT PRESENTED AN INTESTINAL SUBOCCLUSION AND AN ABDOMINAL X-RAY REVEALED CAPSULE RETENTION (CR) LOCATED ON THE RIGHT LOWER ABDOMINAL QUADRANT, CONFIRMED BY COMPUTERIZED TOMOGRAPHY (CT) SCAN. ELECTIVE LAPAROSCOPIC SURGERY INTENDED FOR STENOSIS CORRECTION AND CAPSULE WITHDRAWAL WAS PERFORMED, REVEALING EXTENSIVE SMALL BOWEL DISEASE AND ADHERENCES. THE CAPSULE WAS NOT DETECTED AND ADHERENCES DISSOLUTION WAS PERFORMED. AFTER 4 MONTHS, A NEW ABDOMINAL X-RAY REVEALED 3 METALLIC IMAGES IN DIFFERENT INTESTINAL SEGMENTS SUGGESTING CAPSULE FRAGMENTATION (CF). A COMPUTERIZED TOMOGRAPHY (CT) SCAN CONFIRMED THIS FINDING AND DETECTED THE PRESENCE OF MULTIPLE SMALL BOWEL STENOTIC AREAS. (PUBLICATION IS ATTACHED).

    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 UNK Hospitalization| R