The customer reported a cut on the nipple which was treated with a prescribed topical cream.The flange size may not have been appropriate, as customer had not sized per the instructions for use.Customer continued to pump and breastfeed throughout.The device has not yet been returned to exploramed nc7 for evaluation.A manufacturing review was conducted on the device history record and no nonconformances were noted in the production of this device.Based on the information provided, it cannot be definitively concluded that the willow breast pump caused or contributed to the nipple injury.
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