BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLES CONDOM

    MDR report key: 2919836 · Received January 14, 2013

    Report

    Report Number
    1019632-2013-00003
    Event Type
    Other
    Date Received
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    NA
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS LLC THAT WHILE HAVING INTERCOURSE, A LIFESTYLES CONDOM BROKE AND THEY HAD TO GO TO THE HOSPITAL AND OBTAIN POST EXPOSURE PROPHYLAXIS, WHICH THEY HAD TO TAKE FOR AN ENTIRE MONTH. ALSO, ADVISED THE MEDICATION NEGATIVELY AFFECTED THEIR ABILITY TO PERFORM AT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20565 LIFESTYLES CONDOM NA HIS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other