BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMAFLOAT LAL CONTROL UNIT

    MDR report key: 4892502 · Received July 2, 2015

    Report

    Report Number
    3009402404-2015-00020
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 1, 2015
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY THE END USER, PER THE END USER THE RESIDENT HAS FEMUR BROKEN IN BOTH LEGS AND HAS A CAST ON EACH LEG. THE RESIDENT SET UP IN BED, LEANED TO THE SIDE AND FELL OUT OF THE BED. THE RESIDENT WAS SENT TO THE HOSPITAL. ONE FEMUR WAS DISPLACED AND SURGERY WAS REQUIRED. THE JOERNS TECH VISITED THE FACILITY ON (B)(6) 2015 TO INSPECT THE MATTRESS AND CONTROL UNIT INVOLVED IN THE INCIDENT. THE MATTRESS AND CONTROL UNIT PASSED A COMPLETE FUNCTIONALITY CHECK AND WAS SECURED TO THE BED FRAME PROPERLY. (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431423 DERMAFLOAT LAL CONTROL UNIT AIR MATTRESS CONTROL UNIT FNM JOERNS HEALTHCARE DFLAL-CU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization