BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHWR COMMODE 5 IN CASTER 18 INW 9153640951

    MDR report key: 4365704 · Received December 29, 2014

    Report

    Report Number
    1531186-2014-06995
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Report Date
    November 17, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY A HOSPITAL REPRESENTATIVE THAT 22 SHOWER COMMODE CHAIR, MODEL 6891, HAD CLIPS ON THE BOTTOM OF THE SEAT THAT ARE CRACKING, SEATS CRACKING, AND/OR WELDS BREAKING ON THE LEGRESTS. THE HOSPITAL REPRESENTATIVE ADVISED THAT THE SERIAL NUMBER ON THESE SHOWER COMMODE CHAIRS HAVE GAVE WAY TO WASHING, CAUSING THE SERIAL NUMBERS TO BE ILLEGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853102 SHWR COMMODE 5 IN CASTER 18 INW 9153640951 ADAPTOR, HYGIENE ILS UNKNOWN 6891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other