FDA Warning on Shock Risk of Breast Pumps

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By JENNIFER CORBETT DOOREN

The Food and Drug Administration said baby-products maker Evenflo Co. failed to properly investigate some complaints involving women who reported receiving electrical shocks while using the company's breast pumps. In an Aug. 25 warning letter released by the agency Tuesday, the FDA said it found manufacturing violations at two Ohio plants that make pumps used by women to express breast milk. The breast pumps are sold nationwide under the "Comfort Select" brand name. Evenflo, of Miamisburg, Ohio, is private firm that makes a variety of baby products including toys, high chairs, car seats and strollers.

The FDA warning letter stemmed from inspections of two Evenflo facilities in January and February. Since then, the FDA and the company have worked to address violations of FDA manufacturing rules, with Evenflo providing monthly updates to the agency.

During the inspections, the FDA found Evenflo wasn't in compliance with the agency's manufacturing practice rules, including "failure to review and evaluate all complaints" and for failing "to establish medical device reporting procedures for your breast pumps." Companies are required to report problems with devices to the FDA.

The agency said it reviewed 37 complaints and, of those, 18 weren't investigated by the company, including at least three reports of women receiving an electrical shock when using the breast pumps. The FDA said companies are required to investigate complaints that involve "the possible failure of a device to meet any of its specifications."

Amy Neff, Evenflo's associate general counsel, said the company does investigate its consumer complaints but said the problem was a "documentation issue." In its letter, the FDA said the company's response to the complaint-investigation problem is now "adequate." However, on the medical-device reporting problem, the FDA said the company has yet to fully address the agency's concerns.

Lindsay Harris, Evenflo's vice president of quality and product integrity, said, "We are working cooperatively with the FDA" to address the agency's concerns. He said the company reports all device complaints to the agency.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com