BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERIC YELLOW ISOLATION GOWN WITH CARBON AND TIES AT NECK AND WAIST

    MDR report key: 10127406 · Received June 8, 2020

    Report

    Report Number
    0001527185-2020-00002
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 30, 2020
    Manufacturer
    STANDARD TEXTILE CO., INC.
    Product Code
    OEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE BUT A REPRESENTATIVE SAMPLE OF CIRCULATING INVENTORY WAS PROVIDED. EVALUATION SUMMARY: AN AAMI LEVEL 1 GOWN IS NOT THE RIGHT LEVEL OF PROTECTION WHEN HIGHER VOLUMES OF FLUIDS AND LEANING/PRESSURE IS EXPECTED. THESE CONDITIONS TYPICALLY REQUIRE AAMI LEVEL 2 OR HIGH PERFORMANCE. AAMI LEVEL 1 GOWNS ARE ONLY REQUIRED TO PROVIDE <4.5 GRAMS OF IMPACT RESISTANCE (SIMULATING SPRAY OR SPLATTERING), NO HYDROSTATIC TESTING. INTENDED USE OF AAMI 1 LEVEL PRODUCTS IS WHEN MINIMAL LIQUID CONTACT IS EXPECTED AND NO PRESSING, LEANING OR PRESSURE. CONCLUSIONS: 1. PURCHASED (NEW) PRECAUTION GOWN #6699458P MET SPECIFICATIONS. 2. LAUNDERED PERFORMANCE OF CIRCULATING INVENTORY WAS LOWER THAN EXPECTED BUT STILL MET AAMI LEVEL 1 PERFORMANCE (0.2 G IMPACT PENETRATION). 3. EXPOSURE CONDITIONS INCLUDING HIGHER VOLUMES OF FLUIDS AND LEANING/PRESSURE TYPICALLY REQUIRE AN AAMI LEVEL 2 OR 3 GOWN, I.E., MATERIALS NEED HYDROSTATIC RESISTANCE. LEVEL 1 GOWNS DO NOT HAVE A REQUIREMENT FOR HYDROSTATIC RESISTANCE AND TESTING.

    Additional Manufacturer Narrative · 1

    6/3/2020 - INITIATED REQUEST WITH USER FACILITY FOR ADVERSE EVENT DETAILS (PATIENT INFORMATION, 3RD PARTER RE-PROCESSOR AND EXPOSURE CIRCUMSTANCES) AND REQUESTED PRODUCTS FOR EVALUATION/TESTING.

    Description of Event or Problem · 1

    WHILE CLEANING A C-DIFF PATIENT WHO HAD STOOLED THEMSELVES, MOISTURE WICKED THROUGH THE GOWN AT THE LEG AREA WHILE STAFF WAS LEANING/PRESSING AGAINST SOILED BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590698 GENERIC YELLOW ISOLATION GOWN WITH CARBON AND TIES AT NECK AND WAIST ISOLATION GOWN OEA STANDARD TEXTILE CO., INC. 6699458P 1156379

    Patients

    Seq Age Sex Outcome Treatment
    1 Other