Breast pump adverse events: reports to the food and drug administration.
Breast pumps are medical devices used to express milk and maintain the milk supply. The purpose of this study was to characterize adverse events reported to the United States Food and Drug Administration (FDA) on breast pumps. Thirty-seven adverse event reports on breast pumps were identified from the Manufacturer and User Facility Device Experience database between 1992 and 2003. Four additional reports were found in the Device Experience Network database from 1992 to 1996. The most commonly reported adverse events for electric breast pumps were pain, soreness, or discomfort; the need for medical intervention; and breast tissue damage. Most frequently reported problems for manual breast pumps were breast tissue damage and infection. Contamination of breast milk during pumping was also reported. Breast pump adverse events are likely underreported to the FDA. Reporting adverse events is important for improving the design and manufacture of breast pumps and subsequently decreasing adverse events.
Brown
S Lori
SL
Division of Postmarket Surveillance, Epidemiology Branch, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20850, USA.
Bright
Roselie A
RA
Dwyer
Diane E
DE
Foxman
Betsy
B
D000328:Adult; D001940:Breast / Q000293:injuries / Q000502:physiology*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007774:Lactation; D008893:Milk Ejection / Q000502:physiology*; D008895:Milk, Human / Q000378:metabolism*; D011358:Product Surveillance, Postmarketing; D013396:Suction / Q000009:adverse effects* / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration; D014618:Vacuum