BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPILL® CAPSULE, SINGLE

    MDR report key: 5448522 · Received February 19, 2016

    Report

    Report Number
    9710107-2016-00024
    Event Type
    Injury
    Date Received
    February 19, 2016
    Report Date
    January 20, 2016
    Manufacturer
    GIVEN IMAGING LTD
    Product Code
    NYV
    PMA / PMN Number
    K092342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE INVESTIGATION CANNOT CONFIRM THE REPORTED DEFECT BECAUSE THE INCIDENT SAMPLE WAS NOT RETURNED FOR EVALUATION.  SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT INGESTED A SMARTPILL CAPSULE ON (B)(6), 2015. PATIENT DID NOT PASS CAPSULE AFTER THE 5 DAY STUDY WAS COMPLETED. ON (B)(6) 2015 THE PATIENT REPORTED THAT THE CAPSULE HAD NOT BEEN EXCRETED. (B)(6), 2016 KUB WAS DONE AND THE CAPSULE WAS VISUALIZED. COLONOSCOPY WAS ALSO DONE, THE CAPSULE WAS NOT VISUALIZED. LAXATIVES WERE GIVEN, CAPSULE WAS NOT EXCRETED. ENTEROSCOPY WITH FLUOROSCOPY WAS DONE SHOWING VISUALIZATION OF A NARROWING. THE NARROWING WAS DILATED AND THE CAPSULE WAS REMOVED DURING A SECOND ENTEROSCOPY. PATIENT RECOVERED FROM THE PROCEDURE AND WAS DISCHARGED TO HOME. THE CUSTOMER HAS NOT SEEN THE PATIENT SINCE THE SECOND ENTEROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103672 SMARTPILL® CAPSULE, SINGLE GASTROINTESTINAL MOTILITY SYSTEM CAPSULE NYV GIVEN IMAGING LTD 50100100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention