BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLE EXCITE GEL

    MDR report key: 4744927 · Received April 30, 2015

    Report

    Report Number
    1019632-2015-00006
    Event Type
    Injury
    Date Received
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    SPAN PACKAGING SERVICES
    Product Code
    NUC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (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 AFTER USING LIFESTYLES EXCITE GEL MEDICAL ATTENTION WAS REQUIRED AFTER DEVELOPING BURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284622 LIFESTYLE EXCITE GEL LIQUID PERSONAL LUBRICANT NUC SPAN PACKAGING SERVICES 15017043HC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other