BEUDAMED
    FDA Adverse Event Other Summary report: N

    ILLUSION GLOVE STRAWBERRY

    MDR report key: 2848274 · Received December 29, 2010

    Report

    Report Number
    8040936-2010-00004
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2012
    Manufacturer
    OON CORP. RESOURCES
    Product Code
    FMC
    PMA / PMN Number
    093496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE OFFICE ALLEGES TWO STAFF MEMBERS EXPERIENCED IRRITATION FROM THE GLOVES AS FOLLOWS: (B)(6) FEMALE EXPERIENCED EYE IRRITATION. NONE OF THE STAFF MEMBERS REQUIRED ANY MEDICAL ATTENTION.

    Description of Event or Problem · 2

    THE OFFICE ALLEGES TWO STAFF MEMBERS EXPERIENCED IRRITATION FROM THE GLOVES AS FOLLOWS: (B)(6) FEMALE EXPERIENCED A RASH ON HER HANDS AND EYE IRRITATION. NONE OF THE STAFF MEMBERS REQUIRED ANY MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUSION GLOVE STRAWBERRY LATEX EXAMINATION GLOVE FMC OON CORP. RESOURCES 509070, 510070

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR
    2 33 YR