BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON

    MDR report key: 6289727 · Received January 31, 2017

    Report

    Report Number
    6289727
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    November 8, 2016
    Report Date
    January 5, 2017
    Manufacturer
    REGULATORY INSIGHT INC.
    Product Code
    FOX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ESOPHAGEAL DILATION. AT THE END OF THE PROCEDURE THE OPERATING ROOM TABLE WAS BEING REPOSITIONED. THE IV POLE FELL ONTO THE PATENT'S FACE AND HIT THE PATENT'S LEFT EYE, WHICH CAUSED A LACERATION AS WELL AS DISLOCATION OF THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73024 MCKESSON STAND, INFUSION FOX REGULATORY INSIGHT INC. LP-2814-1102

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S PUMP ON THE IV POLEMULTIPLE IV ACCESS LINES AN