BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCITE GEL

    MDR report key: 1748546 · Received July 2, 2010

    Report

    Report Number
    1019632-2010-00011
    Event Type
    Other
    Date Received
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    SPAN PACKAGING SERVICES
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED SAMPLES FROM THE CUSTOMER. TWO (2 BOTTLES) WERE SENT TO MANUFACTURER TODAY, (B)(4) 2010. A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA AFTER THE INVESTIGATION IS DONE.

    Description of Event or Problem · 1

    CUSTOMER INFORMED THAT SHE HAD EXPERIENCED ITCHING AND SKIN REDNESS AFTER USING LIFESTYLE'S EXCITE GEL. SHE STATED THAT SHE DID NOT NEED MEDICAL ATTENTION; HOWEVER, SHE WAS ABLE TO SPEAK WITH A HEALTH CARE PROVIDER OVER THE PHONE, WHO SUGGESTED APPLYING HYDROCORTISONE CREAM TO THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCITE GEL LIQUID PERSONAL LUBRICANT HIS SPAN PACKAGING SERVICES

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other