Adverse Events Involving Breast Pumps
as Reported to the FDA
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Summary of Adverse Events With Breast Pumps
for the Last Five Years
10/22/2002 Hollister Inc. Breast Pump. Sore nipples and areola from high pressure in breast pump.
10/18/2002 Evenflo Minielectric Breast Pump caused damage and pain to nipple when pumping. Patient had to stop pumping with this pump, due to pain.
08/23/2002 Evenflo Breast Pump. A breastfeeding patient experienced severe nipple pain from using pump. They had to discontinue use of the pump and request another brand of breast pump from the local WIC program, which solved their problem.
08/09/2002 First Years Electric Breast Pump caused pain while pumping and nipple became sore.
07/19/2002 Medela Pump In Style Breast Pump. The diaphragm of the pump developed a hole during normal use. The hole developed over time as user had noticed decreasing suction strength over approx a week's time. The device was completely incapable of expressing breast milk while user was separated from their baby and had no other means to express milk.
06/13/2002 Evenflo Mini Electric Breast Pump failed to express breast milk and hurt nipples.
02/26/2002 Evenflo Electric Battery Operated Single Breast Pump.
This patient needed to use a breast pump to establish and maintain milk supply for baby. The baby was assessed by a lactation consultant as having a suck problem, which is usually correctable over time. Patient bought a battery powered Evenflo pump which was painful to use, when used properly, and resulted in a decreased milk supply.
02/12/2002 First Year’s Double Electric Breast Pump. Patient got breast stuck in breast shield of breast pump during a pumping session. Was only able to remove breast from breast shield by using warm water and vegetable oil. Additionally complained that the breast pump was painful and ineffective in collecting or expressing breast milk for the patient's preterm baby.
12/17/2001 Evenflo Press and Pump Breast Pump. After having a child and breastfeeding the patient got engorged. The patient used the breast pump to pump off excess milk after baby finished nursing. While using the pump patient contracted mastitis. When speaking to a specialist and the doctor, the patient found that the pump the patient was using did not pump evenly and therefore left stagnant milk in the ducts, and also causing a multitude of problems for breasts. Because of the stagnant milk and because some ducts were not being emptied at all patient contracted the mastitis. The pump also caused swollen nipples, tenderness, cracked nipples, and they also bled. Patient ran a temp and had a lot of pain in breast.
11/24/2001 Evenflo Breast Pump did not work. It hurt and user couldn't get any milk out for the baby.
08/23/2001 Evenflo Breast Pump didn't work properly. It did not suck well and it hurt breasts.
06/11/2001 First Years Electric Double Breast Pump. It was taking reporter over an hour to express 1 ounce - it was hurting breasts. Reporter got discouraged. Manufacturer’s response: The event description leads them to believe that the suction release button was not used. The suction release is manual so that the nursing mother can create a comfortable pumping rhythm to reflect a nursing baby. Once the suction is released, the pressure begins to build again. If the suction is not released, the pressure is constant and milk is not expressed.
06/04/2001 A used Medela Pump In Style was purchased at a consignment store. The mfr's inserts included a warning that this is a single use device that should not be sold for reuse. The insert stated that an internal diaphragm could not be effectively sterilized. The consumer was concerned that the store was still selling these used single user devices. Manufacturer response: Medela strongly emphasizes that the Pump In Style is a single user product. Unfortunately Medela Inc can do
no more than warn, to prevent the product from being reused and resold. A consignment store reselling a used single user product is violating the intended use of the product.
04/30/2001 Mag Mag breast pump. The suction release was not working
properly. It was painful when user could not release pressure. Had to remove
batteries to get it off breast.
03/30/2001 The First Years Double Breast Pump was purchased for $60.
Pump does not work. Motor goes on but does not cause breasts to release milk.
Unable to return pump due to nature of product.
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The above is an extract of reports taken by the U.S. Food and Drug
Administration. They are called "adverse event" reports and are taken from the
MAUDE database for 2001 through 2006. Anyone can
file a report with the
FDA about breast pumps or any other medical device. The FDA cautions,
"MAUDE data is not intended to be used either to evaluate rates of adverse
events or to compare adverse event occurrence rates across devices."
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