The customer reported that she was pumping with willow and spectra during the time of the reported mastitis.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.With the information provided, it cannot be definitively concluded that the willow breast pump caused or contributed to the incident of mastitis.Mastitis is usually a benign, self-limiting condition, with few consequences for the suckling infant, with incidence ranging from 4-27%.[1] risk factors include milk stasis, breast engorgement, restriction from tight bra/ clothing, prone sleeping position, maternal stress, excessive fatigue, and malnutrition.[2,3,4,5] wambach, karen, and jan riordan.Breastfeeding and human lactation.5th ed., jones & bartlett learning, 2016.World health organization, mastitis causes & management, 2002.Spencer jp, management of mastitis in breastfeeding women, american family physician.2008; 78 (6): 727-732.Michie c, the challenge of mastitis.Arch dis child.2003: 88, 818-821.Foxman b, lactation mastitis: occurrence and medical management among 946 breastfeeding women in the united states.Am j epidemiol, 155 (2) 2002.
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