BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCITE

    MDR report key: 1961057 · Received December 1, 2010

    Report

    Report Number
    MW5018977
    Event Type
    Other
    Date Received
    December 1, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ANSELL PROTECTIVE PRODUCTS, INC.
    Product Code
    MMS
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MS. (B)(6) STATES THAT SHE WAS DIAGNOSED AS HAVING A SEVERE ALLERGIC REACTION TO THE REFERENCED PRODUCT. MS. (B)(6) STATES THAT THE 1ST SYMPTOM TO DEVELOP WAS ITCHING IN HER GENITAL AREA. MS. (B)(6) STATES THAT APPROX 24 HRS LATER HER GENITALS WERE SWOLLEN AND BLISTERED TO THE EXTENT THAT SHE HAD TO BE CATHETERIZED. MS. (B)(6) STATES THAT SHE WAS ALSO DIAGNOSED AS HAVING A (B)(6) INFECTION WHICH BEGAN AS A RESULT OF THE ALLERGIC REACTION. MS. (B)(6) STATES THAT THIS IS THE FIRST TIME THIS PRODUCT HAS BEEN USED. MS. (B)(6) STATES HOWEVER, THAT ANOTHER BRAND PRODUCT HAS PREVIOUSLY BEEN USED WITHOUT ANY PROBLEMS. HEALTH CARE PROFESSIONAL: (B)(6). PURCHASE DATE: (B)(6) 2010. RETAIL: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCITE FEMALE STIMULATION GEL 15 MILLILITERS BOTTLE MMS ANSELL PROTECTIVE PRODUCTS, INC. 10048505HC

    Patients

    Seq Age Sex Outcome Treatment
    1