Adverse Events Involving Breast Pumps
as Reported to the FDA
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The following 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."
Summary of Breast Pump Adverse Events
for the Last Five Years
12/28/2005 Evenflo Comfort Select Breast Pump not sucking or expressing milk.
12/21/2005 Bailey Nurture III caused nipple and areola tears immediately and during correct usage. Pain is very severe. Mother hopes to be able to continue breastfeeding.
06/28/2005 Playtex Embrace Breast Pump. User pumped for 3 weeks exclusively and observed open wound on their nipple. No additional info.
04/25/2005 Medela Minielectric Lactina Breast Pump. No specific incident. A general complaint that babies may have acquired HIV or hepatitis through expressed milk. Complaint of no instructions from Medela on the responsible way to dispose of a used breast pump.
04/19/2005 Ameda Breast Pump. Outer seal on the box was broken when purchased
03/07/2005 Evenflo Comfort Select Breast Pump. Milk not dropping into the bottle and getting sucked into the motor and coming out where the AC adaptor plugs in
and signs of corrosion. Received a new motor from the manufacturer. Still does the same thing. Unsafe and inconvenient.
07/20/2004 Evenflo Manual Breast
Pump. Breastfeeding patient with plugged ducts bought Evenflo pump. Pump was unable relieve plugged ducts and caused nipple pain.
01/15/2004 The First Years Natural Comfort Breast Pump. Within 24 hours of using this breast pump patient developed several serious blisters on her nipples and had to seek medical advice from a professional. She discontinued use of this product immediately.
12/24/2003 Evenflo Breast Pump leaked, caused painful blister lump on areola and is painful to hands. User called pump “evil.”
09/29/2003 The First Years Easy Comfort Breast Pump. Is unsafe because it pulls milk into the air line and pump assembly, both of which are unable to be cleaned or sterilized. Once milk has entered the line and pump, it cannot be removed and may contaminate milk supplies when used again.
02/05/2003 The First Years Deluxe Electric/Battery Breast Pump Kit.
The pump sucks with long drawn out pulls. This not only hurts but does not achieve any milk collection. In short, it does not work as advertised.
Consulted with a lactation specialist at the hospital, and was told that using the pump could damage the milk glands permanently. As the pump is a sanitary item, it is non-returnable. Manufacturer responded: The event description leads mfr 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 her nursing baby. Once the suction is released, the pressure begins to build again. Important to read instructions.
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