With reference to ISO 4074:2015, Condom is medical device used by consumers, which is intended to be retained on the penis during sexual activity, for purposes of contraception and prevention of sexually transmitted infections. As another device, the condom user may experience a health benefit and health risk caused by material constituents or misuse in some instances. Here is the two risk associate with the use of condom:

1) Severe allergic reaction (among people with latex allergy)

People who have an allergic reaction to rubber gloves or balloons may have a similar reaction to latex condoms. A mild reaction involves redness, itching, rash, or swelling of the skin that comes in contact with latex rubber. A severe reaction involves hives or rash over much of the body, dizziness, difficulty breathing, or loss of consciousness after coming in contact with latex. Both men and women can be allergic to latex and latex condoms.

2) Condoms may break or slip off during sex

On average, about 2% of condoms break, tear, or slip off completely during sex, primarily because they are used incorrectly. Used properly, condoms seldom break. In some studies, with higher breakage rates, often a few users experienced most of the breakage in the entire study. Other studies also suggest that, while most people use condoms correctly, there are a few who consistently misuse condoms, which leads to breaks or slips.

References

1.      ISO 4074:2015 For Natural latex rubber condoms -Requirements and test methods

2.      Family Planning: A Global Handbook for Providers, Chapter 14