FDA Issues Warning To Breast Pump Maker

FDA last month sent a warning letter to a breast pump manufacturer, telling company officials that they should have investigated complaints from women who said the "Comfort Select" pumps electrically shocked them, the Wall Street Journal reports.

FDA found manufacturing violations at two of Evenflo's Ohio plants during inspections in January and February. Evenflo failed to "review and evaluate all complaints," according to FDA, and also failed to "establish medical device reporting procedures." Eighteen of 37 complaints about the products -- including at least three from women who say they were shocked while using the pumps -- were not investigated by the company. An Evenflo spokesperson said that the company is working with FDA to address the agency's concerns (Corbett Dooren, Wall Street Journal, 9/15).


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