BEUDAMED
    FDA Adverse Event Other Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 3354828 · Received September 9, 2013

    Report

    Report Number
    9710107-2013-00221
    Event Type
    Other
    Date Received
    September 9, 2013
    Report Date
    September 9, 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 (B)(6) CAPSULES ARE CONTRAINDICATED FOR USE IN PATIENTS 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 PATIENTS BEFORE ADMINISTRATION OF THE (B)(6) CAPSULE INCLUDING THE AGILE PATENCY SYSTEM, CT ENTEROGRAPHY, OR MR ENTEROGRAPHY.

    Description of Event or Problem · 1

    THE (B)(6) YEARS OLD FEMALE PATIENT TOOK A CAPSULE IN MARCH 2013. TWO WEEKS AGO THE PATIENT STATED THAT SHE HAS STOMACH PAIN. IN AN X-RAY PERFORMED IT APPEARED THAT THE CAPSULE IS STILL IN HER SYSTEM. THE PATIENT IS HAVING SURGERY TO HAVE THE CAPSULE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450662 PILLCAM SB2 CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention