BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMAFLOAT LAL

    MDR report key: 21885708 · Received April 22, 2025

    Report

    Report Number
    3009402404-2025-00012
    Event Type
    Injury
    Date Received
    April 22, 2025
    Report Date
    April 20, 2025
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    UDI-DI
    00857268006103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 ATTORNEY (B)(6), PATIENT WAS HURT ON MATTRESS WHILE ADMITTED (B)(6) 2021 - (B)(6 )2022. JOERNS WAS NOTIFIED OF THIS INCIDENT ON (B)(6) 2025. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290812 DERMAFLOAT LAL PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DFLAL-4280-M 00857268006103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other