BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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    MDR report key: 3082138 · Received April 12, 2013

    Report

    Report Number
    3082138
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    ISOLATION GOWN STUCK TO THE PACKAGING AND UNABLE TO REMOVE IT. ALSO HAS LARGE CRESCENT SHAPED GOUGE OUT OF THE SIDE OF THE GOWN RENDERING IT UNUSABLE.======================MANUFACTURER RESPONSE FOR ISOLATION GOWN, KIMBERLY CLARK ISOLATION GOWN (PER SITE REPORTER).======================E-MAIL SENT TO COMPANY REP, BUT NO RESPONSE YET.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PROTECT STAFF FROM EXPOSRUE TO INFECTIOUS AGENTS FROM PATIENTS IN ISOLATION ROOM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159824 * GOWN, ISOLATION OEA KIMBERLY-CLARK CORPORATION KC200 LG 3 041

    Patients

    Seq Age Sex Outcome Treatment
    1 *