BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLES WARM LOVIN LUBRICANT

    MDR report key: 2867949 · Received September 26, 2012

    Report

    Report Number
    1019632-2012-00009
    Event Type
    Other
    Date Received
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    MKS-MARKEN KOSMETIK SERVICE GMBH & CO KG
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT ON BEHALF OF MARKEN KOSMETIC.

    Description of Event or Problem · 1

    CUSTOMER INFORMED OUR COMPANY THAT AFTER USING THE LUBRICANT, HER SKIN GOT SEVERELY IRRITATED AND HENCE SHE HAD TO SEEK MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLES WARM LOVIN LUBRICANT PERSONAL LUBRICANT HIS MKS-MARKEN KOSMETIK SERVICE GMBH & CO KG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other