BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3090490 · Received May 2, 2013

    Report

    Report Number
    1531186-2013-01874
    Date Received
    May 2, 2013
    Report Date
    April 9, 2013
    Manufacturer
    NEW PROKIN
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER CLAIMS THAT THE SLING RIPPED IN TWO DIFFERENT PLACES. THE PROVIDER CLAIMS THE PATIENT DOES NOT EXCEED WEIGHT CAPACITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192979 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS NEW PROKIN R116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other