09.17.09 FDA issues alert on one brand after cases of shocked nursing moms
A U.S. government agency is accusing baby product maker Evenflo of not fully investigating more than a dozen complaints from women who said they received electrical shocks while using one of the company's breast pumps, The Wall Street Journal reports.
The Food and Drug Administration sent a letter to Evenflo recently saying that the agency had discovered manufacturing problems at two Ohio facilities where the Comfort Select breast pumps are produced. The letter says that the company failed to review, evaluate and then alert the federal agency of all consumer complaints about the breast pump problems.
According to the FDA, its inspectors reviewed 37 complaints and found that 18 were not investigated, with at least three reports from women who said they received electrical shocks when using the Comfort Select.
The FDA does say that it has been working with Evenflo since then in an effort to correct the problems. An Evenflo spokeswoman said the company does investigate its consumer complaints and that the company is working with the FDA to address the agency's concerns about the "documentation issue."
In the real world, most nursing moms are going to need a breast pump at some point. If you're returning to work or just want an occasional break, a pump will help you integrate bottles into your baby's eating routine. Check out our nuts-and-bolts tips on how to pump; plus how to deal with some common roadblocks to expressing breast milk as a working mom. When it's time to buy one, browsing through our basics of pumps will help make your decision easier.
9.18.09 UPDATE—Crib Notes heard from Evenflo. Here is a portion of the company's response to our posting:
"Since the inspection, Evenflo has provided the FDA with several updates ... and the FDA is satisfied with Evenflo's responses to most of the inspection observations. Late last month, the FDA informed Evenflo that several matters remain open. We are confident that we will be able to resolve these matters by continuing to work with the FDA. ... Safety is our core mission at Evenflo, and we are confident that the Comfort Select is safe for moms to use."
Maria Vega is Fit Pregnancy magazine's copy editor.