BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYCARE BED

    MDR report key: 19397770 · Received May 24, 2024

    Report

    Report Number
    3009402404-2024-00024
    Event Type
    Injury
    Date Received
    May 24, 2024
    Report Date
    May 23, 2024
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMTION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT DO NOT KNOW DETAILS OF INCIDENT, BUT THIS WAS REPORTED UNDER LITIGATION TO JOERNS. CURRENTLY IN PROCESS OF GATHERING DETAILS FROM OTHER PARTY. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305830 EASYCARE BED PATIENT BED FNL JOERNS HEALTHCARE ECSBED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other