BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES EXCITE GEL

    MDR report key: 5995176 · Received October 3, 2016

    Report

    Report Number
    1019632-2016-00009
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 19, 2016
    Manufacturer
    SPAN PACKAGING SERVICES D.B.A. MULTI PACK SOLUTION
    Product Code
    NUC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K 021125.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 CUSTOMER DID NOT RETAIN PRODUCT AND COULD NOT PROVIDE A LOT/BATCH NUMBER FOR ANSELL TO CHECK BATCH RECORD INFORMATION. NO OTHER ADVERSE REPORTS OF THIS TYPE HAVE BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    AFTER A REPORT OF (B)(6) FROM END USER, ANSELL FOLLOWED UP TO END USER TO GET ADDITIONAL INFORMATION ON A PRODUCT COMPLAINT. ON (B)(6), END USER INDICATED THAT THEY DEVELOPED A RASH AFTER USING THE PRODUCT. THE END USER CONSULTED WITH A PHYSICIAN WHO INDICATED TO USE AN OVER THE COUNTER PRODUCT SUCH AS VASELINE AND HYDROCORTISONE CREAM.

    Description of Event or Problem · 1

    AFTER A REPORT OF (B)(6) FROM END USER, ANSELL FOLLOWED UP TO END USER TO GET ADDITIONAL INFORMATION ON A PRODUCT COMPLAINT. ON (B)(6), END USER INDICATED THAT THEY DEVELOPED A RASH AFTER USING THE PRODUCT. THE END USER CONSULTED WITH A PHYSICIAN WHO INDICATED TO USE AN OVER THE COUNTER PRODUCT SUCH AS VASOLINE AND HYDROCORTINSONE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645371 LIFESTYLES EXCITE GEL PERSONAL LUBRICANT NUC SPAN PACKAGING SERVICES D.B.A. MULTI PACK SOLUTION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other