BEUDAMED
    FDA Adverse Event Other Summary report: N

    5844-12

    MDR report key: 2401768 · Received December 7, 2011

    Report

    Report Number
    2921578-2011-00035
    Event Type
    Other
    Date Received
    December 7, 2011
    Report Date
    December 5, 2011
    Manufacturer
    MIZUHO OSI
    Product Code
    KME
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE USE OF A PT CARE KIT, THE PT WAS FOUND TO HAVE AN ALLERGIC REACTION WHERE THE KIT TOUCHED THE SKIN. THE PT WAS GIVEN ANTIHISTAMINES AND THE ALLERGIC REACTION SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5844-12 BEDDING, DISPOSABLE KME MIZUHO OSI 5844-12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1