BEUDAMED
    FDA Adverse Event Other Summary report: N

    ILLUSION GLOVE STRAWBERRY

    MDR report key: 2848269 · Received December 29, 2010

    Report

    Report Number
    8040936-2010-00002
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    OON CORP. RESOURCES
    Product Code
    FMC
    PMA / PMN Number
    093496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE RETURNED WERE EVALUATED AND FOUND TO BE IN COMPLIANCE. LABELING AND CAUTION STATEMENTS ARE CLEARLY STATED ON THE PACKAGING.

    Description of Event or Problem · 1

    THE OFFICE ALLEGES FOUR STAFFS MEMBERS BETWEEN THE AGES 26 - 60 EXPERIENCED A RASH AFTER USING LATEX EXAMINATION GLOVES. ONE PERSON WENT TO THE DERMATOLOGIST FOR A PRE-EXISTING CONDITION AND NOT BECAUSE OF THE GLOVES. THE OTHER THREE STAFF MEMBERS DID NOT SEEK ANY MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUSION GLOVE STRAWBERRY LATEX EXAMINATION GLOVES FMC OON CORP. RESOURCES 510070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention