BEUDAMED
    FDA Adverse Event Death Summary report: N

    DERMAFLOAT LAL

    MDR report key: 23045744 · Received September 12, 2025

    Report

    Report Number
    3009402404-2025-00046
    Event Type
    Death
    Date Received
    September 12, 2025
    Report Date
    September 12, 2025
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    UDI-DI
    00857268006097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, 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 PER ETC - ARRIVED TO PICK-UP DFLAL FROM PATIENT'S HOME, DURING THE COURSE OF THE PICK-UP THE PATIENT DAUGHTER, THAT HER MOTHER HAD BEEN CONFUSED OVER THE LAST FEW DAYS AND SHE HAD FOUND HER FACE DOWN ON THE FLOOR UNRESPONSIVE BY THE BED, SHE WAS LATER PRONOUNCED DEAD. DOES NOT SEEM AS IF OUR PRODUCT IS AT FAULT BUT WILL INVESTIGATE PER PROCESS AND RETAIN ON SITE. COMPLAINT # (B)(4) AND RA # (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE UNITS RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THEY HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287640 DERMAFLOAT LAL PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DFLAL-3680-M 00857268006097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death