Medical Devices

Injury and Infection

The first few times you pump may feel uncomfortable but pumping should not be painful, result in sore nipples, or cause bleeding. Pain, sore nipples, and nipple irritation or bleeding may be signs of an injury.

Signs of infection can include soreness, yellowish discharge, a fever, and/or flu-like symptoms, such as feeling run down or very achy. Check with your health care provider if your symptoms do not improve within 24 to 48 hours. Womenshealth.gov provides basic information and advice on dealing with breast infections and other common breastfeeding challenges such as sore nipples and engorgement.

If you are injured or experience persistent pain or bleeding when using your breast pump, contact your doctor, lactation consultant or other health care professional for advice.

If you are having trouble using your pump, a qualified health care professional may be able to help you.

If your pump is not working, contact the manufacturer. Check the box your breast pump came in or call directory assistance for the manufacturer’s contact information.

Reporting an Injury or Infection from a Breast Pump to the FDA

Reporting of injuries and other adverse events can help the FDA identify and better understand potential risks associated with medical devices, like breast pumps. If you suspect a problem with a breast pump, we encourage you to file a voluntary report with the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Things you might not think to report, that should be reported:

  • Pump problems (breaking, not working right)
  • Infections that might be related to the pump
  • Presence of mold or mold-like substances in a pump

How to Contact the FDA with Questions about Breast Pumps

The FDA’s Division of Industry and Consumer Education(DICE) can help answer questions about medical devices. You may contact DICE:

Email: dice@fda.hhs.gov or industry.devices@fda.hhs.gov

Telephone: 1-800-638-2041 or 301-796-7100

Page Last Updated: 10/07/2014
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