BEUDAMED
    FDA Adverse Event Other Summary report: N

    M2A CAPSULE

    MDR report key: 470920 · Received July 1, 2003

    Report

    Report Number
    9710107-2003-00001
    Event Type
    Other
    Date Received
    July 1, 2003
    Date of Event
    March 20, 2003
    Report Date
    April 14, 2003
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING OFFICE VISIT FOR ANEMIA, CAPSULE INGESTED ABOUT 6 MONTHS AGO HAS BEEN SEEN IN X-RAY IN SEVERAL PIECES. SURGERY WAS SCHEDULED FOR TREATING THE STRICTURES HOLDING THE CAPSULE PIECES. SURGERY WAS PERFORMED DURING WHICH 12 CROHN RELATED STRICTURES HAVE BEEN TREATED AND CAPSULE PIECES SUCCESSFULLY REMOVED. PATIENT IS WELL AND ADDITIONAL HANDLING IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A CAPSULE WIRELESS CAPSULE NEZ GIVEN IMAGING LTD. * PS000031

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other