BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANSELL

    MDR report key: 3365755 · Received September 18, 2013

    Report

    Report Number
    MW5031971
    Event Type
    Other
    Date Received
    September 18, 2013
    Report Date
    September 18, 2013
    Manufacturer
    ANSELL
    Product Code
    LYY
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER COMPLAINED ABOUT A FOUL ODOR FROM THE ANSELL VINYL-TOCH GLOVES. THIS PRODUCT WHICH IS MADE IN CHINA EMITS A VERY STRONG AND FOUL ODOR AS SOON AS THE BOX IS OPENED. THE CALLER IS CONCERNED THAT THESE GLOVES COULD BE INFLAMMABLE OR THEY COULD BE A HEALTH HAZARD. HE STATED THAT HIS WIFE USES THE GLOVES FOR EVERY DAY HOUSE CHORES AND FOR BATHING AND FEEDING HER DAUGHTER. THE CALLER HAS CALLED THE MFR AND LEFT VOICE MESSAGES, BUT NOBODY HAS CALLED BACK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471264 ANSELL VINYL-TOUCH GLOVES LYY ANSELL 13054088DF

    Patients

    Seq Age Sex Outcome Treatment
    1