BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 5527452 · Received March 25, 2016

    Report

    Report Number
    9710107-2016-00104
    Event Type
    Injury
    Date Received
    March 25, 2016
    Report Date
    February 28, 2016
    Manufacturer
    GIVEN IMAGING LTD
    Product Code
    NEZ
    PMA / PMN Number
    K101250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT WITH A RETAINED SB2 CAPSULE. THE PATIENT HAD UNDERGONE A SMALL BOWEL ENDOSCOPY IN 2004 AND WAS DIAGNOSED WITH CROHN'S DISEASE. THE CAPSULE WAS RETAINED AND NEVER REACHED THE CECUM. ACCORDING TO A CT SCAN TAKEN IN (B)(6) 2016, THE CAPSULE WAS STILL FOUND TO BE INSIDE THE BODY LOCATED IN THE ILEAL LOOP. THE PATIENT IS CLINICALLY ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182866 PILLCAM SB2 CAPSULE SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING LTD FGS-0495

    Patients

    Seq Age Sex Outcome Treatment
    1 Other