BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLE ULTRA THIN

    MDR report key: 1950864 · Received December 10, 2010

    Report

    Report Number
    1019632-2010-00021
    Event Type
    Injury
    Date Received
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    SURETEX LTD.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER USED THE LIFESTYLES ULTRA THIN CONDOMS AND TWICE THE TOP TORE OFF COMPLETELY. THIS FORCED HER TO GO TO THE HOSPITAL TO HAVE THE MISSING PIECE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLE ULTRA THIN LUBRICATED LATEX CONDOM HIS SURETEX LTD. 1009750200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other