BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLE SKYN

    MDR report key: 3786178 · Received April 15, 2014

    Report

    Report Number
    1019632-2014-00006
    Event Type
    Injury
    Date Received
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    SURETEX LTD
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT THE LIFESTYLES POLYISOPRENE LUBRICATED CONDOM SHE USED CAUSED AN IRRITATION THAT REQUIRED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230830 LIFESTYLE SKYN LUBRICATED POLYISOPRENE CONDOM HIS SURETEX LTD 1311120422

    Patients

    Seq Age Sex Outcome Treatment
    1 Other