BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYBER-GEL LATEX POWDER FREE GLOVE

    MDR report key: 2848288 · Received April 21, 2010

    Report

    Report Number
    8040936-2010-00001
    Event Type
    Other
    Date Received
    April 21, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    OON CORP. RESOURCES
    Product Code
    FMC
    PMA / PMN Number
    981917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. LABELING AND CAUTION STATEMENTS ARE CLEARLY STATED ON THE PACKAGING.

    Description of Event or Problem · 1

    THE OFFICE CLAIMS ONE OF THEIR STAFF MEMBERS WHO IS HIGHLY SENSITIVE TO LATEX EXPERIENCED AN ALLERGIC REACTION TO THE LATEX GLOVES THAT WERE IN THE OFFICE. THE STAFF MEMBER USUALLY DOES NOT WORK IN THE AREA WHERE THE GLOVES ARE MAINTAINED; HOWEVER, SHE WAS COVERING FOR ANOTHER STAFF MEMBER AND STARTED TO EXPERIENCE DIFFICULTY BREATHING AND SWELLING OF HER THROAT. SHE WENT TO HER ENT SPECIALIST AND ALLERGIST FOR TREATMENT AND WAS PRESCRIBED BENADRYL AND PREDNISONE. SHE IS NOW FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBER-GEL LATEX POWDER FREE GLOVE LATEX POWDER FREE GLOVE FMC OON CORP. RESOURCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention