BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLE SKYN

    MDR report key: 4394373 · Received January 6, 2015

    Report

    Report Number
    1019632-2015-00001
    Event Type
    Injury
    Date Received
    January 6, 2015
    Report Date
    January 6, 2014
    Manufacturer
    SURETEX LTD.
    Product Code
    MOL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLE POLYISOPRENE LUBRICATED CONDOM SHE SUFFERED FROM A BACTERIA INFECTION THAT REQUIRED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10104 LIFESTYLE SKYN LUBRICATD POLYISOPRENE CONDOM MOL SURETEX LTD. 1401101022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O