BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO + BASIC

    MDR report key: 3110553 · Received April 4, 2013

    Report

    Report Number
    1419652-2013-00086
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE: 'BOTH CONCERTO AND PATIENT ON IT HAVE FALLEN ONTO THE FLOOR. NO SERIOUS INJURY TILL NOW. EVENT HAPPENED WHEN CARER WAS GETTING THE CLIENTS WHEELCHAIR - PROBABLY AT THE BEGINNING OF LAST WEEK. CONCERTO IS KEPT "OUT OF ORDER" FOR INVESTIGATION. SERVICE IS DONE BY 3RD PARTY.' MFR REF NUMBER 9611530-2013-00031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139550 CONCERTO + BASIC SHOWER SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB BAB1107-01

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other