BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTRYLES EXTRA STRENGTH

    MDR report key: 2640026 · Received August 15, 2011

    Report

    Report Number
    1019632-2011-00006
    Event Type
    Other
    Date Received
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    SURETEX LTD.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4) - ANSELL HEALTHCARE PRODUCTS IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). RETURNED SAMPLES FROM THE CUSTOMER WERE RECEIVED ON (B)(4) 2011 AND WERE MAILED TO THE MANUFACTURER ON 08/15/2011. A FOLLOW UP REPORT WILL BE SENT TO FDA ASAP WITH ADDITIONAL INFORMATION ABOUT THE FACTORY INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER SENT A COMPLAINT TO OUR COMPANY INFORMING THAT SHE HAS USED LIFESTYLES EXTRA STRENGTH AND BECAME PREGNANT. ON (B)(6) 2011, SHE CONTACTED US TO INFORM THAT SHE NEEDED MEDICAL ATTENTION TO BE TESTED FOR STDS. ACCORDING TO HER, ALL THOSE RESULTS CAME BACK AS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTRYLES EXTRA STRENGTH LUBRICATED LATEX CONDOMS HIS SURETEX LTD. 0812090916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other