BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLUE IMPERVIOUS GOWN XL

    MDR report key: 6054817 · Received October 20, 2016

    Report

    Report Number
    6054817
    Event Type
    Other
    Date Received
    October 20, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    CARDINAL HEALTH
    Product Code
    OEA
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLUE IMPERVIOUS XL GOWNS LOT# 608231 250 EA, THEY ALL DON'T HAVE LOT NUMBERS ON THEM. SOME HAVE THE LOT ON THE SIDE OF BOX WHICH IS UNREADABLE AND IF LOT NUMBER IS ON SIDE OF BOX AND THERE IS A LOT NUMBER ON FRONT OF BOX, IT DOESN'T MATCH. CAT #AT4441 THEY ARE MADE BY CARDINAL HEALTH. QTY 75 IN ONE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696986 BLUE IMPERVIOUS GOWN XL BLUE IMPERVIOUS GOWN W/THUMBROOKS OEA CARDINAL HEALTH AT4441 608231

    Patients

    Seq Age Sex Outcome Treatment
    1