BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACARE BED

    MDR report key: 2559536 · Received May 1, 2012

    Report

    Report Number
    1824206-2012-02428
    Event Type
    Injury
    Date Received
    May 1, 2012
    Date of Event
    September 1, 2011
    Report Date
    April 10, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNTS RISK MANAGEMENT DEPARTMENT DECLINED TO RELEASE ANY INFO REGARDING THE PT OR THE BED AND WOULD NOT CONFIRM IF THE PT WAS ADMITTED AT THEIR FACILITY.

    Description of Event or Problem · 1

    THE PT STATED SHE WAS IN THE HOSPITAL FOR BACK SURGERY (DISCECTOMY), AND WAS PLACED ON A VERSACARE BED WITH THE A.I.R. MATTRESS. THE PT COMPLAINED TO THE NURSING STAFF THAT THE MATTRESS WAS CAUSING HER BACK TO HURT BECAUSE IT WAS CONSTANTLY INFLATING/DEFLATING, MAKING IT FEEL LIKE A METAL ROD WAS BEING PUSHED INTO HER BACK. THE PT STATED SHE HAD ANOTHER OPERATION A WEEK LATER AND IS STILL HAVING COMPLICATIONS. SHE FEELS THIS WAS A DIRECT RESULT OF BEING PLACED ON THIS BED IMMEDIATELY FOLLOWING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK