BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES

    MDR report key: 4109382 · Received September 15, 2014

    Report

    Report Number
    1019632-2014-00013
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    UNK
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES PRODUCT SHE HAD TO GO TO THE EMERGENCY ROOM TO HAVE THE CONDOM REMOVED AS IT WAS LODGED UP BENEATH HER CERVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569014 LIFESTYLES UNKNOWN HIS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other