BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLCAM

    MDR report key: 8035262 · Received November 2, 2018

    Report

    Report Number
    9710107-2018-01023
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Report Date
    November 2, 2018
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    PMA / PMN Number
    K123666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE WIRELESS CAPSULE ENDOSCOPY IN ADOLESCENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS SOURCE TUMORI , VOLUME 102, 2016 (40-44) DATE OF PUBLICATION: 15 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, THREE PATIENTS WERE UNABLE TO SWALLOW THE VIDEO CAPSULE, AND IT WAS POSITIONED DIRECTLY INTO THE STOMACH BY THE UPPER GASTROINTESTINAL SCOPE. IN THIS STUDY, NO PATIENT EXPERIENCED CAPSULE RETENTION AND NO OTHER COMPLICATIONS, SUCH AS BLEEDING OR PERFORATION WERE OBSERVED. ARTICLE: WIRELESS CAPSULE ENDOSCOPY IN ADOLESCENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS AUTHOR: MARCO VITELLARO, MD, YEAR: 2015 JUNE VOLUME 102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874576 PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0520

    Patients

    Seq Age Sex Outcome Treatment
    1