BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSOCAM PLUS

    MDR report key: 7233008 · Received January 31, 2018

    Report

    Report Number
    3008062894-2018-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    November 28, 2017
    Report Date
    January 31, 2018
    Manufacturer
    CAPSOVISION INC.
    Product Code
    NEZ
    PMA / PMN Number
    K161773
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED TO THE HEALTH CARE FACILITY THE CAPSULE WAS EXCRETED IN PIECES. DATE OF THE CAPSULE RETRIEVAL IS UNKNOWN AS THE PATIENT COULD NOT BE REACHED UNTIL (B)(6) 2017, 1 MONTH AFTER INGESTING THE CAPSULE ON (B)(6) 2017. THE CAPSULE COMPONENTS WERE DISCARDED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74528 CAPSOCAM PLUS SMALL BOWEL CAPSULE ENDOSCOPE NEZ CAPSOVISION INC. SV-3 02-17-0030

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR