BEUDAMED
    FDA Adverse Event Death Summary report: N

    DERMAFLOAT LAL SYSTEM

    MDR report key: 8357418 · Received February 21, 2019

    Report

    Report Number
    3009402404-2019-00012
    Event Type
    Death
    Date Received
    February 21, 2019
    Date of Event
    February 15, 2019
    Report Date
    February 21, 2019
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, " (B)(6) SAID THE MATTRESS "WEDGE DEFLATED AND SHE FELL OUT OF THE MATTRESS AND ENDED UP ON THE FLOOR AND DIED AS A RESULT OF OUR MATTRESS"." (B)(4) AND (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE MATTRESS AND CONTROL UNIT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, THE MATTRESS AND CONTROL UNIT HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150953 DERMAFLOAT LAL SYSTEM PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DFLAL-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death