BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4468372 · Received January 28, 2015

    Report

    Report Number
    1019632-2015-00003
    Event Type
    Injury
    Date Received
    January 28, 2015
    Report Date
    January 28, 2015
    Manufacturer
    UNK
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANSELL HEALTHCARE PRODUCT, LLC IS SUBMITTING THIS REPORT ON BEHALF OF UNK MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES PREMIUM LATEX CONDOM SHE DEVELOPED A YEAST INFECTION THAT REQUIRED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64223 UNKNOWN PREMIUM LATEX CONDOM HIS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other