BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPHYLACTIC LATEX SPERMICIDE LUBRICATED NONOXYNOL-9

    MDR report key: 286108 · Received July 17, 2000

    Report

    Report Number
    MW1019300
    Event Type
    Malfunction
    Date Received
    July 17, 2000
    Report Date
    July 7, 2000
    Manufacturer
    HANKOOK LATEX GONGUP CO., LTD.
    Product Code
    LTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NUMEROUS COMPLAINTS RECEIVED BY LOCAL PUBLIC HEALTH OFFICE REGARDING SUBJECT BRAND NAME CONDOM PROPHYLACTIC. ITEM RUPTURES OR BREAKS DURING SEXUAL INTERCOURSE; GREAT POTENTIAL FOR UNWARRANTED PREGNANCIES AND TRANSMISSION OF SEXUALLY TRANSMITTED DISEASES INCLUDING HIV/AIDS. CONSULTATION WITH OTHER PUBLIC HEALTH OFFICES CONFIRM SIMILAR COMPLAINTS. CONTACTED A TOTAL OF 36 OFFICES, EIGHT OFFICES DISTRIBUTED SAME BRAND CONDOM. SIX OF THE EIGHT OFFICES VOICES THE SAME COMPLAINT. EACH OFFICE QUESTIONED CONSUMERS REGARDING METHOD OF CONDOM USE (E.G., ORAL/ANAL SEX, IMPROPER USE, ETC). BREAKAGE OCCURRED DURING VAGINAL INTERCOURSE, SINGLE CONDOM USE, WITH NO ADD'L LUBRICANT USE. IT IS SUSPECTED THAT BREAKAGE COULD BE CAUSED BY SUBSTANDARD MATERIAL OR MFG, AND NOT CONSUMER MISUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPHYLACTIC LATEX SPERMICIDE LUBRICATED NONOXYNOL-9 CONDOM LTZ HANKOOK LATEX GONGUP CO., LTD. * 9CX035-P

    Patients

    Seq Age Sex Outcome Treatment
    1 *