BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS

    MDR report key: 7075918 · Received December 1, 2017

    Report

    Report Number
    1528319-2017-00035
    Event Type
    Injury
    Date Received
    December 1, 2017
    Report Date
    December 1, 2017
    Manufacturer
    ENDOAID, LTD.
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE ENDORINGS DEVICE DETACHED FROM THE END OF THE ENDOSCOPE IN THE PATIENT'S RECTUM DURING A PROCEDURE. THE DEVICE WAS RETRIEVED USING A FORCEPS. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR USER. US ENDOSCOPY IS THE IMPORTER OF THIS DEVICE AND IS FILING THIS 3500A AS SUCH. THE MANUFACTURER, ENDOAID HAS BEEN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854797 ENDORINGS ENDORINGS FED ENDOAID, LTD. E103 10300205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention