BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES EXCITE GEL

    MDR report key: 3465880 · Received November 5, 2013

    Report

    Report Number
    1019632-2013-00021
    Event Type
    Injury
    Date Received
    November 5, 2013
    Report Date
    November 5, 2013
    Manufacturer
    SPAN PACKAGING SERVICES
    Product Code
    NUC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT 3 DAYS AFTER INITIAL USE OF LIFESTYLES EXCITE GEL, MEDICAL ATTENTION WAS REQUIRED AFTER DEVELOPING FEVER/CHILLS AND BURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569305 LIFESTYLES EXCITE GEL LIQUID PERSONAL LUBRICANT NUC SPAN PACKAGING SERVICES 13063830HC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other