BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTYLES, LUBRICATED WITH NONOXYNOL-9

    MDR report key: 36338 · Received August 29, 1996

    Report

    Report Number
    MW1009822
    Event Type
    Malfunction
    Date Received
    August 29, 1996
    Date of Event
    July 20, 1996
    Report Date
    August 21, 1996
    Manufacturer
    ANSELL CORP. ANSELL HEALTHCARE
    Product Code
    LTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERSON REPORTS THAT CONDOM BROKE DURING SEXUAL INTERCOURSE. THIS HAPPENED AGAIN WITH SAME BATCH OF CONDOMS. ALSO TEN OTHER PEOPLE COMPLAINED OF BREAKAGE AFTER GETTING CONDOMS FROM FACILITY. ONLY 200 HAD BEEN DISTRIBUTED AT THAT TIME. THESE PEOPLE HAD RECEIVED INFO ON THE CORRECT USAGE OF CONDOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLES, LUBRICATED WITH NONOXYNOL-9 CONDOM LTZ ANSELL CORP. ANSELL HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR