BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3800075 · Received May 8, 2014

    Report

    Report Number
    1531186-2014-01698
    Date Received
    May 8, 2014
    Report Date
    April 1, 2014
    Manufacturer
    LERADO GLOBAL
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    END USER STATED THAT THE LAMINATION THAT GOES AROUND THE RIM OF THE TABLE ON A (B)(4) OVER THE BED TABLE IS TOO SHARP, USER SUSTAINED BRUISING OF HER ARMS WHEN LEANING ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278742 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS LERADO GLOBAL 6417

    Patients

    Seq Age Sex Outcome Treatment
    1 68 MO Other