BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT TOUCH SIDE RAILS

    MDR report key: 3037394 · Received March 27, 2013

    Report

    Report Number
    1931947-2013-00001
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 28, 2013
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AT 10:30 AM ON (B)(6), (B)(6) CALLED TO REPORT AN INCIDENT THAT ALLEGEDLY INVOLVED THE FOLLOWING PRODUCT OR DEVICE: ASSIST RAILS FOR THE ELITE RISER ELECTRIC BED. VINCE MORANO REPORTED THAT THE FOLLOWING OCCURRED ON MORNING OF (B)(6): RESIDENT WENT TO ROLL OVER, THE RAIL SNAPPED AND HE FELL OUT OF BED. THE FOLLOWING INJURIES ALLEGEDLY OCCURRED: HE HIT HIS HEAD ON THE FLOOR. (B)(6) REPORTED THAT THE INJURED PARTY WAS TREATED AT A HOSPITAL/CLINIC AND RELEASED. THE PRODUCT HAS BEEN TAKEN OUT OF USE. THE RESIDENT'S APPROXIMATE WEIGHT IS OVER (B)(6). (B)(6) SAID THAT AT THE TIME OF THE INCIDENT HE WAS NOT SURE IF THERE WERE OTHER PEOPLE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126188 SOFT TOUCH SIDE RAILS HOSPITAL BED SIDE RAILS FNL NOA MEDICAL INDUSTRIES, INC. 7540010BEI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization