BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PILLCAM

    MDR report key: 14377958 · Received May 12, 2022

    Report

    Report Number
    9710107-2022-00121
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    August 12, 2021
    Report Date
    May 12, 2022
    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: DOES CAPSULE ENDOSCOPY IMPACT CLINICAL MANAGEMENT IN ESTABLISHED CROHN¿S DISEASE? SOURCE: DIGESTIVE AND LIVER DISEASE 54 (2022) 118¿124 JOURNAL HOMEPAGE: WWW.ELSEVIER.COM/LOCATE/DLD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY FROM 2008 TO 2019, EVALUATED THE CLINICAL IMPACT OF SMALL BOWEL CAPSULE ENDOSCOPY (SBCE) IN PATIENTS WITH ESTABLISHED CROHN¿S DISEASE. A TOTAL OF 432 SBCE PROCEDURES IN 305 PATIENTS WERE INCLUDED. SBCE WAS PERFORMED WITH THE FOLLOWING REPORTED COMPLICATIONS: DATA GAPS IN 26 STUDIES WHERE THE AUTHORS INDICATE THAT THESE GAPS DID NOT COMPROMISE THE DIAGNOSTIC YIELD AND 11 CASES OF CAPSULE RETENTION. ONE PATIENT REQUIRED ENDOSCOPIC RETRIEVAL OF THE CAPSULE AFTER FAILED MEDICAL THERAPY WITH CORTICOSTEROIDS. MEDICAL MANAGEMENT OF THE OTHER 10 INSTANCES OF CAPSULE RETENTION (NOT REQUIRING ENDOSCOPIC RETRIEVAL) ARE NOT DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064528 UNKNOWN PILLCAM NEZ GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention