BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMAFLOAT LAL SYSTEM

    MDR report key: 8789673 · Received July 15, 2019

    Report

    Report Number
    3009402404-2019-00044
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    June 29, 2019
    Report Date
    July 15, 2019
    Manufacturer
    FXI
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, WHEN PATIENT TRIED TO GET BACK INTO BED AFTER VISITING THE BATHROOM HE SAID HE SLIPPED OFF THE BED AND FELL ON THE FLOOR. THE PATIENT SUSTAINED BANGING OF THE ARM/HAND/NECK, HAS A BLACK EYE AND A MUSCLE STRAIN. (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
    582521 DERMAFLOAT LAL SYSTEM PATIENT AIR MATTRESS FNM FXI DFLAL-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR