Major OUCH!! Women Say They Were Shocked By Breast Pumps

Sep 162009
 

Via the Women’s Health Policy Report:

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.

Thanks to Abigail’s worried Great Grandma for passing this along!

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 Posted by Fempeace on September 16, 2009

  One Response to “Major OUCH!! Women Say They Were Shocked By Breast Pumps”

  1. admin says:
    September 18, 2009 at 8:37 am

    I received the following response via email from Evenflo:

    Dear Lucinda,
    I saw your post about the Comfort Select breast pump yesterday, and wanted to provide some additional context and explain the situation.
    Earlier this year, the FDA conducted a routine inspection of our Miamisburg and Piqua, Ohio manufacturing facilities. At the conclusion of its inspection, the FDA made some observations about Evenflo’s internal procedures. Since the inspection, Evenflo has provided the FDA with several updates – including supplementary documentation and information on how the company is enhancing its internal written procedures – 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 expect to respond to the FDA’s recent letter within the next week, and are confident that we will be able to resolve these matters by continuing to work with the FDA.

    With regard to consumer complaints about electrical shock, these reports have been investigated to the extent that information or the product was available to the company. We have provided information to the FDA regarding our investigation of these reports, and the FDA has determined our response to be adequate.

    Safety is our core mission at Evenflo, and we are confident that the Comfort Select is safe for moms to use. I appreciate your time and the opportunity to share this information with you. Please let me know if you have any questions.

    Don Huber

    Director, Product Integrity
    evenflo

    Evenflo Company, Inc. | 225 Byers Road, Miamisburg, OH 45342 | Office: (937) 415-3188 | Mobile: (937) 829-3853 | Email: don.huber@evenflo.com

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