BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCAIR PLUS MATTRESS

    MDR report key: 6267861 · Received January 20, 2017

    Report

    Report Number
    3009402404-2017-00003
    Event Type
    Injury
    Date Received
    January 20, 2017
    Date of Event
    January 11, 2017
    Report Date
    January 20, 2017
    Manufacturer
    FXI
    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, THE PATIENT COMPLAINED THAT THEY WERE GETTING BED SORES FROM THE MATTRESS. THE PATIENT SUSTAINED A RIGHT GLUTEAL CLEFT-STAGE 1 AND IS BEING TREATED/MONITORED BY (B)(6). (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
    49945 PROCAIR PLUS MATTRESS PATIENT AIR MATTRESS FNM FXI 222-3684

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Hospitalization