BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCAIR PLUS MATTRESS

    MDR report key: 9741204 · Received February 21, 2020

    Report

    Report Number
    3009402404-2020-00017
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 21, 2020
    Manufacturer
    FXI
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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, CARETAKER CHANGING SHEETS WHILE PATIENT WAS ON EQUIPMENT AND DURING THE PROCESS PATIENT MOVED TO THE SIDE TO QUICKLY AND FELL OFF THE EQUIPMENT. THE PATIENT WAS TAKEN TO THE HOSPITAL AND SUSTAINED INJURIES TO THE RIGHT SIDE OF THE BODY. COMPLAINT# (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205455 PROCAIR PLUS MATTRESS PATIENT AIR MATTRESS FNM FXI 222-3684

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization