BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM PLUS

    MDR report key: 12069579 · Received June 25, 2021

    Report

    Report Number
    3008062894-2021-00002
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 25, 2021
    Manufacturer
    CAPSOVISION, INC.
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021 INGESTION OF CAPSULE. ON (B)(6) 2021 ADMITTED FOR SMALL BOWEL OBSTRUCTION. ON (B)(6) 2021 PATIENT DISCHARGED. ON (B)(6) 2021 SURGICAL PROCEDURE TO REMOVE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968313 CAPSOCAM PLUS SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC. SV-3 01-19-0070

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R