BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALF SIDE RAIL

    MDR report key: 3853500 · Received May 30, 2014

    Report

    Report Number
    1417592-2014-00055
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAUGHTER WAS CARING FOR HER MOTHER AT HOME THE MOTHER AS SUFFERING FROM DEMENTIA AND WAS PARALYZED ON ONE SIDE DUE TO A PREVIOUS STROKE. THE DAUGHTER REPORTED THAT HER MOTHER WAS CONFUSED, UNCOOPERATIVE AND WAS THRASHING AROUND IN THE BED WHILE BEING BATHED. THE DAUGHTER STATED SHE WAS PARTIALLY LAYING OVER THE SIDE RAIL AND ON TOP OF HER MOTHER IN AN ATTEMPT TO MINIMIZE THE THRASHING. IN THE THRASHING, THE MOTHER WAS PARTIALLY OFF OF THE BED AND HER LEG HIT UP AGAINST THE SIDE RAIL. SHE SUFFERED A LACERATION THAT WAS REPAIRED WITH SUTURES. THE DME COMPANY INSPECTED THE SIDE RAIL AND DETERMINED THAT IT DID NOT MALFUNCTION. THERE WERE NO SHARP EDGES OR DEFORMITIES REPORTED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WE HAVE NOT HAD ANY OTHER SIMILAR INCIDENTS REPORTED TO US FOR THIS DEVICE.

    Description of Event or Problem · 1

    THE ENDUSER SUFFERED A LEG LACERATION FROM HITTING THE SIDE RAIL THAT WAS REPAIRED WITH SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318170 HALF SIDE RAIL FNL MEDLINE INDUSTRIES, INC. S310473757

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other