BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLES ULTRA SENSITIVE

    MDR report key: 720996 · Received May 31, 2006

    Report

    Report Number
    1019632-2006-00003
    Event Type
    Other
    Date Received
    May 31, 2006
    Report Date
    May 31, 2006
    Manufacturer
    SURETEX PROPHYLACTICS (INDIA)LIMITED
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER USING LIFESTYLES CONDOMS, BOTH PARTNERS EXPERIENCED REACTIONS IN THE FORM OF GENITAL BLEMISHES WHICH CAUSED MUCH PAIN IN THE MOST PERSONAL PLACE. MEDICAL ATTENTIONS WAS REQUIRED FOR BOTH PARTNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLES ULTRA SENSITIVE CONTRACEPTIVE DEVICE HIS SURETEX PROPHYLACTICS (INDIA)LIMITED 1712 0510051722

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other