BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBT

    MDR report key: 1070906 · Received June 30, 2008

    Report

    Report Number
    2182305-2008-00023
    Event Type
    Injury
    Date Received
    June 30, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 6, 2008
    Manufacturer
    JOERNS HEALTHCARE, INC.
    Product Code
    INW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A NON MEDICAL DEVICE COMPLAINT. HOWEVER, THE DEGREE OF INJURY TO RESIDENT WAS SERIOUS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR, BY FACILITY; PER FACILITY, A RESIDENT SLID A CUP OF COFFEE ACROSS THE OBT [OVER BED TABLE] AND THE CUP "CAUGHT ON THE EDGE OF THE TABLE TOP" AND SPILLED ONTO HIS LAP CAUSING 2ND AND 3RD DEGREE BURNS. THE STATE OF MI HAS BEEN CALLED. PER THE MFR, THE EDGE OF THE T-MOULD REMAINS PROUD OF THE TABLE TOP EDGE FOR MULTIPLE REASONS. FIRST, THE LIP AIDS IN SPILL PROTECTION, THE LIP HELPS TO RETAIN FLUID ON THE TABLE TOP IF A SPILL OCCURS. SECONDLY, IT IS VERY IMPORTANT THAT THE CORE MATERIAL OF THE TABLE TOP IS NOT EXPOSED TO MOISTURE/FLUIDS AS THIS CAN CREATE A POTENTIAL FOR WATER DAMAGE TO THE CORE MATERIAL. SUCH EXPOSURE CAN ALSO CREATE THE POTENTIAL FOR FOSTERING BACTERIA. THE OTHER ISSUE AND A CONCERN FOR THE MFR WAS THE QUESTION AS TO WHY A FACILITY WOULD BE SERVICING ANY LIQUID AT THIS TEMPERATURE THAT WOULD CAUSE SECOND AND THIRD DEGREE BURNS TO THEIR RESIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBT OVER BED TABLE INW JOERNS HEALTHCARE, INC. OBT200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O