BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES

    MDR report key: 4309898 · Received December 4, 2014

    Report

    Report Number
    1019632-2014-00016
    Event Type
    Injury
    Date Received
    December 4, 2014
    Report Date
    December 4, 2014
    Manufacturer
    UNK
    Product Code
    LTZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). - ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT ON BEHALF OF UNK MFR.

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES CONDOM THAT CONTAINED SPERMICIDE NONOXYNOL-9 HE RECEIVED A SEVERE SKIN BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782931 LIFESTYLES UNK LTZ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other