BEUDAMED
    FDA Adverse Event Other Summary report: N

    ILLUSION GLOVE STRAWBERRY

    MDR report key: 2848353 · Received December 29, 2010

    Report

    Report Number
    8040936-2010-00006
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    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

    UNABLE TO EVALUATE SPECIFICALLY THE DEVICE DUE TO UNKNOWN LOT NUMBER. HOWEVER, 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.

    Additional Manufacturer Narrative · 2

    UNABLE TO EVALUATE SPECIFICALLY THE DEVICE DUE TO UNKNOWN LOT NUMBER. HOWEVER, 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 · 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR
    2 57 YR