BEUDAMED
    FDA Adverse Event Summary report: N

    FLORENCE BED

    MDR report key: 3832302 · Received January 6, 2014

    Report

    Report Number
    3009591865-2013-00001
    Date Received
    January 6, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 18, 2013
    Manufacturer
    GROUPE BERTEC INC
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR COULD NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE CAUSE OF THE SITUATION OR THE SERIAL NUMBER OF THE BED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT LEG WAS IN BETWEEN THE BARS OF THE FL23SE SIDERAILS AND THE PATIENT MOVED THEIR LEG TO THE NARROWER SECTION OF THE SIDERAILS AND IT BECAME CAUGHT. NO INJURY OTHER THAN REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8509 FLORENCE BED HOSPITAL BED, A-C POWERED ADJUSTABLE FNL GROUPE BERTEC INC FL23SE FL23SE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other