BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2534324 · Received April 13, 2012

    Report

    Report Number
    1531186-2012-00131
    Date Received
    April 13, 2012
    Report Date
    April 12, 2012
    Manufacturer
    UNKNOWN
    Product Code
    KMN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER STATED THAT SHE LEANED ON THE OVERBED TABLE TO GET INTO BED AND THE BASE CAME APART, ALLEGEDLY CAUSING HER TO FALL. THE CONSUMER HAD RECENT BRAIN SURGERY PRIOR TO THE INCIDENT. THE CONSUMER STATED THAT SHE WAS GOING TO THE DOCTOR FOR OTHER REASONS AND FOR THE FALL AS WELL. THE CONSUMER STATED THAT SHE FALLS FREQUENTLY AND HAS ISSUES WITH REMEMBERING. INVACARE OVERBED TABLES HAVE A WEIGHT LIMITATION OF 25 LBS. THE TABLES ARE NOT INTENDED TO BE USED FOR ASSISTANCE GETTING INTO OR OUT OF BED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED OVERBED TABLE CAME APART FROM THE BASE. MINOR INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 KMN UNKNOWN 6400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other