BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3944290 · Received July 18, 2014

    Report

    Report Number
    1531186-2014-02600
    Date Received
    July 18, 2014
    Report Date
    June 10, 2014
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE MATTRESS ON A (B)(4) SEMI ELECTRIC BED IS LUMPY, CAUSING USER TO GET PINCHED WHEN GETTING INTO OR OUT OF THE BED. MINOR INJURY, NO MEDICAL INTERVENTION SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421250 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL LAND AMERICA HEALTH & FITNESS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other