BEUDAMED
    FDA Adverse Event Injury Summary report: N

    300 WOUND SURFACE

    MDR report key: 3122673 · Received May 17, 2013

    Report

    Report Number
    1045510-2013-00013
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    APEX MEDICAL CORP.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM BECAME AWARE OF A PATIENT THAT ALLEGEDLY SUSTAINED A HAIRLINE FRACTURE TO THEIR LOWER BACK ON ONE OF ITS IMPORTED DEVICES, THE 300 WOUND SURFACE. THE CAREGIVER ALLEGED THE BLADDERS IN THE SEAT SECTION OF THE MATTRESS WOULD GET DISPLACED OR SEPARATE WHEN THE HEAD OF BED WAS RAISED, LEAVING THE PATIENT RESTING ON THE BED FRAME IN AN ELEVATED POSITION. THE CAREGIVER ALLEGED THE PATIENT SUFFERED A HAIRLINE FRACTURE IN THEIR BACK DUE TO RESTING ON THE BED FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219127 300 WOUND SURFACE MATTRESS, AIR FLOTATION ALTERNATING PRESSURE FNM APEX MEDICAL CORP. 4937

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention