Evenflo Didn’t Follow Up on Reports of Electrical Shocks from Breast Pumps, FDA Says

Evenflo Co., a leading maker of baby products, did not fully investigate more than a dozen complaints from women who said they received electrical shocks while using the company’s breast pumps, the Food and Drug Administration said.

The FDA sent a letter to Evenflo last month saying the agency had found manufacturing problems at two Ohio facilities where the “Comfort Select” brand breast pumps are produced. A copy of the letter was released this week, according to a report in The Wall Street Journal.

During FDA inspections in January and February 2009, authorities determined that Evenflo had failed to review and evaluate all consumer complaints about problems with its breast pumps. The company also failed to “establish medical device reporting procedures” for the products, according to the FDA letter. The FDA has been working with Evenflo since then in an effort to correct the problems, the agency said.

Companies such as Evenflo are required to report reports they receive from consumers about problems with their products directly to the FDA, but the company failed to do so in some cases, the FDA said. Manufacturers are required to investigate consumer complaints that involve “the possible failure of a device to meet any of its specifications,” the FDA said.

According to the FDA, its inspectors reviewed 37 complaints and found that 18 were not investigated by the company. In at least three reports, women said they received an electrical shock when using the breast pumps.

An attorney for Evenflo told the Journal that the whole problem appears to be a “documentation issue,” which suggests the company contends that it actually did follow up on the consumer complaints, but just didn’t dot the I’s and cross the T’s to document that it had done so. (Well, what did you expect Evenflo’s attorney to say, that the company knowingly violated federal laws regarding reporting of such complaints?)

For its part, the FDA says Evenflo has not yet fully addressed the agency’s concerns about following up on consumer complaints regarding the breast pumps.

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