BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDOVATIONS INNERVISION DETACHABLE BOUGIE TIPS 50F

    MDR report key: 7673391 · Received July 9, 2018

    Report

    Report Number
    MW5078295
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    May 16, 2018
    Report Date
    July 6, 2018
    Manufacturer
    MEDOVATIONS INC. / DIVERSATEK HEALTHCARE INC.
    Product Code
    FDG
    UDI-DI
    00816734021293
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 50F BOUGIE TIP BECAME DISLODGED FROM THE ILLUMINATION CORD IN THE PT'S ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510940 MEDOVATIONS INNERVISION DETACHABLE BOUGIE TIPS 50F RETRACTOR, FIBEROPTIC FDG MEDOVATIONS INC. / DIVERSATEK HEALTHCARE INC. 1465-50 221575 00816734021293

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention