BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESS KIT

    MDR report key: 177701 · Received July 1, 1998

    Report

    Report Number
    MW1014187
    Event Type
    Malfunction
    Date Received
    July 1, 1998
    Report Date
    June 24, 1998
    Manufacturer
    ECOLAB, INC.
    Product Code
    FMC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RECENTLY THERE WAS A BLOOD SPILL IN A SHOP. WHEN WORKPLACE PERSONNEL OPENED THE BLOOD SPILL CLEAN-UP KIT, THEY FOUND THE GLOVES HAD HOLES. ULTIMATELY 6 KITS WERE OPENED AND 3 WERE FOUND TO CONTAIN GLOVES WITH HOLES. THERE IS NO EXPIRATION DATE ON THE KIT. ANOTHER ORGANIZATION OPENED A KIT AND ALSO FOUND THE GLOVES TO HAVE HOLES. WHEN FACILITY FIRST BEGAN USING THE KITS IN 1995, THEY WERE TOLD BY THE CO THERE WAS NO EXPIRATION DATE. THERE IS A PACKAGING DATE BUT NOT EXPIRATION DATE ON THE BLOOD SPILL CLEAN UP KIT. THIS POTENTIALLY CREATED A PROBLEM IN ALL AREAS WHERE THISE KITS ARE KEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESS KIT BLOOD SPILL CLEAN-UP KIT. FMC ECOLAB, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *