BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES CONDOM

    MDR report key: 3514528 · Received November 22, 2013

    Report

    Report Number
    1019632-2013-00022
    Event Type
    Injury
    Date Received
    November 22, 2013
    Report Date
    November 22, 2013
    Manufacturer
    UNK
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANSELL HEALTHCARE PRODUCTS, LLC IS SUBMITTING THIS REPORT ON BEHALF OF MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES CONDOM, MEDICAL ATTENTION WAS REQUIRED FOR BURNING AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609665 LIFESTYLES CONDOM LIFESTYLES LATEX CONDOM HIS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other