BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2483447 · Received March 4, 2012

    Report

    Report Number
    9710107-2012-00864
    Event Type
    Injury
    Date Received
    March 4, 2012
    Report Date
    February 29, 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

    GIVEN IMAGING LABELING, SUCH AS USER MANUAL INDICATE THAT PILLCAM SB CAPSULES ARE CONTRAINDICATED FOR USE IN PTS WITH KNOWN OR SUSPECTED GASTROINTESTINAL OBSTRUCTION, STRICTURES, OR FISTULAS BASED ON THE CLINICAL PICTURE OR PRE PROCEDURE TESTING AND PROFILE. DIAGNOSTIC TOOLS ARE AVAILABLE TO PHYSICIANS TO ASSESS PTS BEFORE ADMINISTRATION OF THE PILLCAM SB CAPSULE INCLUDING THE AGILE PATENCY SYSTEM, CT ENTEROGRAPHY, OR MR ENTEROGRAPHY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON A PT WITH A RETAINED PILLCAM SB CAPSULE SINCE (B)(6) 2010. THE REASON IN UNCLEAR AND THE PT DOES NOT HAVE CROHN'S DISEASE. ORIGINALLY SHE WAS BEING WORKED UP FOR OBSCURE GASTROINTESTINAL BLEEDING. SHE DOES HAVE A HISTORY OF ABDOMINAL SURGERY, AND MAY HAVE DEVELOPED POSTOPERATIVE ADHESIONS OF THE BOWEL WHICH LED TO CAPSULE RETENTION. WHEN THE SURGEON RAN THE BOWEL, THERE WAS NO EVIDENCE OF LARGE DIVERTICULA. THE PT WAS HOSPITALIZED WITH OBSTRUCTIVE SYMPTOMS, THOUGH SHE IS BETTER TODAY AND ABLE TO TAKE CLEAR LIQUIDS. ON X-RAY THE CAPSULE APPEARS TO BE LOW IN THE GI TRACT BUT THE PRECISE LOCATION IS UNKNOWN. FURTHER INFORMATION IS UNAVAILABLE.

    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