The customer reported sepsis, secondary to mastitis, treated by intravenous and oral antibiotics.The customer may have been using an incorrect flange size, as she noted using a 30.5 flange with another pump (outside of willow's range of flange sizes).The customer noted pumping during treatment using an alternate pump.The initiating factor in this situation, mastitis, is primarily caused by 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.Mastitis is usually a benign, self-limiting condition, with few consequences to the infant and incidence ranging from 4-27%.The device has not 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 wearable breast pump caused or contributed to the incident of mastitis.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.Wambach, karen, and jan riordan.Breastfeeding and human lactation.5th ed., jones & bartlett learning, 2016.
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