BEUDAMED
    FDA Adverse Event Other Summary report: N

    ILLUSION GLOVE STRAWBERRY

    MDR report key: 2848293 · Received December 29, 2010

    Report

    Report Number
    8040936-2010-00003
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 4, 2010
    Manufacturer
    OON CORP. RESOURCES
    Product Code
    FMC
    PMA / PMN Number
    093496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: LOT # 666070. 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 SEVEN TO EIGHT STAFF MEMBERS BETWEEN THE AGES OF 23 - 40 EXPERIENCED A REACTION AND A BURNING SENSATION ON THEIR HANDS THAT LASTED A FEW DAYS AFTER USING LATEX EXAMINATION GLOVES. ONE PERSON DEVELOPED A SORE AND WAS ADMINISTERED CORTISONE CREAM; HOWEVER, THE OTHER 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 GLOVE FMC OON CORP. RESOURCES 670070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention