BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4191705 · Received October 22, 2014

    Report

    Report Number
    1525712-2014-07151
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 17, 2014
    Manufacturer
    UNKNOWN
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATED THAT SHE WAS GETTING OUT OF THE UNKNOWN MODEL BED, HAD 1 LEG ON THE FLOOR AND HER KNEE ON THE BED. AS SHE WAS MOVING HER LEG TO THE FLOOR SHE FELT A SCRAPE AND WENT INTO SHOCK. END USER STATED SHE SCREAMED NON STOP FOR OVER 30 MINUTES. STATES SHE LOST A LOT OF BLOOD AND IT TOOK OVER AN HOUR AT THE EMERGENCY ROOM TO REATTACH HER SKIN. END USER STATES THAT THE POST WHERE THE BED RAILS GO INTO THE BED CAUGHT HER LEG AND PULLED THE SKIN UP, TEARING THE MEAT BACKWARD. END USER STATED SHE WAS IN A LOT OF PAIN, A GOUGE OF SKIN WAS CUT LOOSE FROM THE BACK OF HER LEG. HE I JURY ALLEGEDLY REQUIRED 3 STITCHES, ONE IN EACH CORNER TO HOLD THE CHUNK OF SKIN IN PLACE AND 18 STAPLES TO SEAL THE SKINS 3 AREAS. END USER IS REQUIRED TO WEAR A BOOT TO KEEP HER FROM BENDING HER TOES DOWNWARD AND RIPPING THE SKIN BACK OPEN. INVACARE SPOKE TO THE END USER WHO STATED THAT SHE SAW A SPIDER ON THE WALL AND WAS SCARED, TRIED TO GET OUT OF BED IN A HURRY AND ALLEGES THAT THE BED RAIL SOCKET WAS SHARP AND RIPPED HER SKIN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673886 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R