BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES ULTRA SENSITIVE

    MDR report key: 4093234 · Received September 4, 2014

    Report

    Report Number
    1019632-2014-00012
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    SURETEX LTD
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES ULTRA SENSITIVE LUBRICATED CONDOM HIS PARTNER BROKE OUT IN A SKIN RASH THAT REQUIRED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539499 LIFESTYLES ULTRA SENSITIVE LUBRICATED LATEX CONDOM HIS SURETEX LTD 131204011C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other