The customer was sent replacement 21mm personal fit breast shields so that she could return them to a retail location for a refund and her original breast shields were requested to be returned for testing/evaluation.The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).Reported issues of rash were investigated under (b)(4), which determined the root cause to be potential for the product, after it is opened, to come in contact with environmental allergens, lotions or creams, and cleaning solutions that may cause an allergic reaction or irritation.Such root cause is not a product malfunction or a deficiency in information available to the user.
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On (b)(6) 2020, the customer alleged to medela llc that the 21mm personal fit breast shields she was using with her pump in style breast pump had caused her to develop a rash.She additionally alleged that she had seen a dermatologist and her obgyn doctor, who advised her that it was an allergic reaction to polypropylene and she was prescribed a steroid as treatment for two weeks.
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