BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PILLCAM

    MDR report key: 12923214 · Received December 3, 2021

    Report

    Report Number
    9710107-2021-00488
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    January 16, 2018
    Report Date
    December 3, 2021
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: ROLE OF CAPSULE ENDOSCOPY IN ALARM FEATURES AND NONRESPONSIVE CELIAC DISEASE: A EUROPEAN MULTICENTER STUDY SOURCE: DIGESTIVE ENDOSCOPY 2018; 30: 461¿466 DOI: 10.1111/DEN.13002. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2003 AND 2015, A STUDY WAS PERFORMED TO ANALYZE THE USEFULNESS OF CE(CAPSULE ENDOSCOPY) IN THE SUSPICION OF COMPLICATED CELIAC DISEASE (CD). ONE HUNDRED AND EIGHTY-NINE CELIAC PATIENTS (MEAN AGE:46.6 16.6, 30.2% MALES) WHO UNDERWENT CE FOR ALARM SYMPTOMS (N = 86, 45.5%) OR NON-RESPONSIVE CD (N = 103, 54.5%) WERE INCLUDED. A SINGLE CE RETENTION WITH A SUCCESSIVE SURGICAL EXTRACTION WAS REPORTED. AN ULCERATED ILEAL SUBSTENOSIS LEADING TO CE RETENTION WAS ALSO REPORTED IN ONE OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827498 UNKNOWN PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C NEZ GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention