The customer reported mastitis which was treated by doctor prescribed iv antibiotics.The willow device has not yet been 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.Based on 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 to the infant and incidence ranging from 4-27%.A primary cause of mastitis is milk stasis within the breast, providing a medium for bacterial growth.There are a variety of risk factors for mastitis, including missed or restricted feedings, breast engorgement, restriction from tight bra/ clothing, prone sleeping position, maternal stress, excessive fatigue, and malnutrition.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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