BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-SMARTPILL

    MDR report key: 8232189 · Received January 9, 2019

    Report

    Report Number
    9710107-2019-00017
    Event Type
    Injury
    Date Received
    January 9, 2019
    Date of Event
    March 13, 2017
    Report Date
    January 9, 2019
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NYV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ROLE OF WIRELESS MOTILITY CAPSULE IN THE ASSESSMENT AND MANAGEMENT OF GASTROINTESTINAL DYSMOTILITY IN PATIENTS WITH DIABETES MELLITUS. SOURCE: (B)(6), DEPARTMENT OF GASTROENTEROLOGY AND HEPATOLOGY. DATE: OCT 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT HAD A CAPSULE RETAINED IN THE STOMACH, WHO WAS LATER FOUND TO HAVE A GASTRIC OUTLET OBSTRUCTION DURING ENDOSCOPY FOR CAPSULE RETRIEVAL AND WAS EVENTUALLY DIAGNOSED WITH METASTATIC CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24989 UNK-SMARTPILL GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE NYV GIVEN IMAGING LTD., YOQNEAM UNKNOWN SMARTPILL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other