BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANE/SLING SEAT

    MDR report key: 4379892 · Received December 29, 2014

    Report

    Report Number
    MW5039885
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    December 14, 2014
    Report Date
    December 29, 2014
    Manufacturer
    AMPLE SOURCE TRADING COMPANY
    Product Code
    KHY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER WAS IN HER ELEVATOR SITTING ON HER CANE SLING SEAT AND THE SEAM BROKE ON ONE OF THE SIDES OF THE SEAT, CAUSING HER TO FALL TO THE GROUND. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: USED AS A MOBILITY AID AND CHAIR FOR REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854612 CANE/SLING SEAT CANE/SLING SEAT KHY AMPLE SOURCE TRADING COMPANY SST6856

    Patients

    Seq Age Sex Outcome Treatment
    1