BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM

    MDR report key: 8035216 · Received November 2, 2018

    Report

    Report Number
    9710107-2018-01022
    Event Type
    Injury
    Date Received
    November 2, 2018
    Report Date
    November 2, 2018
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NSI
    UDI-DI
    07290101360629
    PMA / PMN Number
    K090557
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE DETECTION OF SMALL BOWEL MUCOSAL HEALING AND DEEP REMISSION IN PATIENTS WITH KNOWN SMALL BOWEL CROHN¿S DISEASE USING BIOMARKERS, CAPSULE ENDOSCOPY, AND IMAGING SOURCE THE AMERICAN JOURNAL OF GASTROENTEROLOGY, VOLUME 110, 2015(1316-1323) DATE OF PUBLICATION: 28 JULY 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, ONE PATIENT HAD A SYMPTOMATIC PATENCY CAPSULE RETENTION MANIFESTING WITH ABDOMINAL PAIN AND VOMITING. THE PATIENT WAS TREATED WITH CORTICOSTEROIDS WITH SUBSEQUENT RESOLUTION OF THE SYMPTOMS WITHIN 2 DAYS. ARTICLE: DETECTION OF SMALL BOWEL MUCOSAL HEALING AND DEEP REMISSION IN PATIENTS WITH KNOWN SMALL BOWEL CROHN¿S DISEASE USING BIOMARKERS, CAPSULE ENDOSCOPY, AND IMAGING AUTHOR: URI KOPYLOV , MD, YEAR: 2015 SEPTEMBER VOLUME110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873629 PILLCAM SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE NSI GIVEN IMAGING LTD., YOQNEAM FGS-0109 07290101360629

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention