BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES UNKNOWN

    MDR report key: 3402732 · Received October 3, 2013

    Report

    Report Number
    1019632-2013-00020
    Event Type
    Injury
    Date Received
    October 3, 2013
    Report Date
    October 3, 2013
    Manufacturer
    UNK
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4) -ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT ON BEHALF OF MANUFACTURE (UNKNOWN).

    Description of Event or Problem · 1

    CUSTOMER ADVISED ANSELL THAT WHILE USING A LIFESTYLES BRAND CONDOM THE TIP BROKE OFF INSIDE HER WHICH CAUSED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500887 LIFESTYLES UNKNOWN UNKNOWN HIS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other