BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM PLUS

    MDR report key: 14114244 · Received April 14, 2022

    Report

    Report Number
    3008062894-2022-00001
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 1, 2021
    Report Date
    April 14, 2022
    Manufacturer
    CAPSOVISION, INC.
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022 CAPSULE PROCEDURE WAS INITIATED BY (B)(6). PATIENT TOLERATED PREP AND CAPSULE INGESTION. ON (B)(6) 2022 KUB X-RAY PERFORMED TO CONFIRM CAPSULE HAS NOT BEEN PASSED. ­ PATIENT WAS REFERRED TO (B)(6). ­ DOUBLE BALLOON PERFORMED AND REMOVED THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247394 CAPSOCAM PLUS SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC. SV-3 01-21-0357

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention