BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLES XTRA PLEASURE RIBBED

    MDR report key: 794831 · Received December 8, 2006

    Report

    Report Number
    1019632-2006-00010
    Event Type
    Other
    Date Received
    December 8, 2006
    Report Date
    December 8, 2006
    Manufacturer
    ANSELL HEALTHCARE
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER DISCOVERED 2 RIPS IN HER VAGINA. CUSTOMER WENT TO THE DOCTOR. CUSTOMER STATED THAT CUTS HAVE BEEN MADE BY CHAFING OF THE CONDOM AND THAT LUBRICATION USED ON THE CONDOMS HAVE CAUSED THE CUTS TO BE MILDLY INFECTED AND INFLAMED. PER DOCTOR'S SUGGESTION. CUSTOMER DISCONTINUED USE OF LIFESTYLES XTRA PLEASURE RIBBED CONDOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLES XTRA PLEASURE RIBBED CONTRACEPTIVE DEVICE HIS ANSELL HEALTHCARE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other