The device was not returned to exploramed nc7 for evaluation; however, a manufacturing review was conducted on the device history record and no nonconformances were noted in the production of this device the initial user report stated that she pumped for a prolonged duration before feeling the symptoms associated with the onset of mastitis.Subsequent follow-up communication with the user shows that she continues to use willow and has not had a reoccurrence of mastitis.With the information provided, it cannot be definitively concluded that the willow breast pump caused or contributed to the incident of mastitis.The user also uses another commercial breast pump."mastitis is usually a benign, self-limiting condition, with few consequences for the suckling infant.In worldwide studies published within the last 20 years, the incidence of lactation mastitis ranged from 4% to 27%." wambach, karen, and jan riordan.Breastfeeding and human lactation.5th ed., jones & bartlett learning, 2016.
|