BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTA GARD YELLOW ISOLATION MASK

    MDR report key: 1671183 · Received April 21, 2010

    Report

    Report Number
    1423507-2010-00021
    Event Type
    Other
    Date Received
    April 21, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 21, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. NO SAMPLE WAS PROVIDED, THEREFORE, THE ROOT CAUSE COULD NOT BE ASSIGNED. DURING THE PRODUCT DEVELOPMENT PHASE, ALL MATERIALS USED FOR THE MASK WERE EVALUATED FOR BIOCOMPATIBILITY. THERE HAVE BEEN NO CHANGES TO THE MATERIALS USED. THE TESTS UTILIZED ARE DESIGNED TO PREDICT THE SAFETY OF THE PRODUCT FOR THE GENERAL POPULATION OF USERS. UNFORTUNATELY NO TEST OR SERIES OF TESTS CAN GUARANTEE THAT A PARTICULAR ITEM WILL BE COMPATIBLE WITH ALL USERS. WE WILL CONTINUE TO MONITOR OUR CUSTOMER BASE FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    A DIETARY WORKER DEVELOPED A RASH, SAW A PHYSICIAN, AND HAS MISSED TIME FROM WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTA GARD YELLOW ISOLATION MASK ISOLATION MASK FXX CARDINAL HEALTH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other