BEUDAMED
    FDA Adverse Event Death Summary report: N

    INX

    MDR report key: 17035017 · Received May 31, 2023

    Report

    Report Number
    1523574-2023-00014
    Event Type
    Death
    Date Received
    May 31, 2023
    Date of Event
    March 19, 2023
    Report Date
    May 31, 2023
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A FERNO SALES REPRESENTATIVE RECEIVED A COMMUNICATION ALLEGING A FERNO STRETCHER WAS INVOLVED IN A ROLLOVER AMBULANCE ACCIDENT RESULTING IN A PATIENT DEATH. THE ACCIDENT WAS NOT REPORTED TO FERNO AT THE TIME OF OCCURRENCE AND INVOLVEMENT OF THE ALLEGED FERNO STRETCHER HAS NOT BEEN CONFIRMED. THERE HAVE BEEN NO REPORTS OF ALLEGED PRODUCT MALFUNCTION BEING A FACTOR IN THE ALLEGED INCIDENT. AN ONLINE ARTICLE STATED " THE TRANSIT VAN LEFT THE ROADWAY AND ROLLED; THERE WAS SNOW AND ICE ON THE FREEWAY AT THE TIME OF THE ACCIDENT". NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029999 INX INX FPO FERNO-WASHINGTON, INC. 0015811

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Death