BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2892096 · Received December 28, 2012

    Report

    Report Number
    2892096
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    March 30, 2012
    Report Date
    December 28, 2012
    Manufacturer
    DURO-MED INDUSTRIES
    Product Code
    FLH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT (B)(6) SAT ON BEDSIDE COMMODE. THE SEAT AND THE CONTAINER COLLAPSED ONTO THE FLOOR WITH PATIENT ENDING UP WEDGED IN THE FRAME. THE WEIGHT LIMIT OF THE BEDSIDE COMMODE WAS 250 LBS.HOSPITAL MAINTENANCE STAFF PUT TOGETHER THE BEDSIDE COMMODE, AS IT IS NOT SHIPPED AS A WHOLE UNIT. UNSURE IF THIS CAUSED THE ERROR OR IF THE EQUIPMENT WAS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BODY WASTE RECEPTACLE FLH DURO-MED INDUSTRIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR NO OTHER THERAPIES