BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION SYSTEM

    MDR report key: 7062850 · Received November 28, 2017

    Report

    Report Number
    1317307-2017-00017
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 11, 2017
    Manufacturer
    CARESTREAM HEALTH
    Product Code
    IZL
    PMA / PMN Number
    K141837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THAT THERE WAS NO DEVICE MALFUNCTION. THE USER ACCIDENTALLY DROVE THE REVOLUTION OVER THE INDIVIDUAL'S FOOT RESULTING IN THE BROKEN BONE. THEREFORE, SINCE THIS WAS CAUSED BY THE USER'S ACTIONS, THERE IS NO FURTHER ACTION REQUIRED BY CARESTREAM HEALTH. THE SITE DID NOT REPORT THIS INCIDENT TO CARESTREAM HEALTH AT THE TIME IT OCCURRED. THE SITE INFORMED CARESTREAM HEALTH ON NOVEMBER 14TH, 2017 AND STATED THAT IT HAPPENED SOMETIME IN (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THAT THERE WAS NO DEVICE MALFUNCTION. THE USER ACCIDENTALLY DROVE THE REVOLUTION OVER THE INDIVIDUAL'S FOOT RESULTING IN THE BROKEN BONE. THEREFORE, SINCE THIS WAS CAUSED BY THE USER'S ACTIONS, THERE IS NO FURTHER ACTION REQUIRED BY CARESTREAM HEALTH. THE SITE DID NOT REPORT THIS INCIDENT TO CARESTREAM HEALTH AT THE TIME IT OCCURRED. THE SITE INFORMED CARESTREAM HEALTH ON NOVEMBER 14TH, 2017 AND STATED THAT IT HAPPENED SOMETIME IN (B)(6) 2017. ON 11 DEC 2017 - THE INITIAL REPORT SUBMITTED ON NOV 28 2017 LISTED THE INCORRECT COUNTRY WHERE EVENT OCCURRED. THE CORRECT COUNTRY IS BELGIUM. FOLLOW UP 1 CONTAINS THIS CORRECTION ONLY.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THERE WAS AN INCIDENT IN AT THE HOSPITAL IN WHICH A USER DROVE OVER THE FOOT OF AN INDIVIDUAL, RESULTING IN A BROKEN BONE IN THE INDIVIDUAL'S FOOT.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THERE WAS AN INCIDENT IN AT THE HOSPITAL IN WHICH A USER DROVE OVER THE FOOT OF AN INDIVIDUAL, RESULTING IN A BROKEN BONE IN THE INDIVIDUAL'S FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842971 DRX REVOLUTION SYSTEM DRX REVOLUTION IZL CARESTREAM HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other