MAUDE Adverse Event Report: EXPLORAMED NC7, INC. WILLOW WEARABLE BREAST PUMP; POWERED BREAST PUMP

Model Number	PDW29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer is an exclusive pumper (pumps but does not breastfeed).During the week prior to the reported mastitis, customer reported that she was pumping with another breast pump (medela) and only pumped once with willow.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%.[1] a primary cause of mastitis is milk stasis within the breast, providing a medium for bacterial growth.[2,3,4] 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.[2,3,4,5] 1.Wambach, karen, and jan riordan.Breastfeeding and human lactation.5th ed., jones & bartlett learning, 2016.2.World health organization, mastitis causes & management, 2002.3.Spencer jp, management of mastitis in breastfeeding women, american family physician.2008; 78 (6): 727-732.4.Michie c, the challenge of mastitis.Arch dis child.2003: 88, 818-821.5.Foxman b, lactation mastitis: occurrence and medical management among 946 breastfeeding women in the united states.Am j epidemiol, 155 (2) 2002.
Event or Problem Description
The customer reported to willow customer care that on (b)(6) 2019 she was treated for mastitis.The customer reported that during the week preceding the reported mastitis, she was pumping with another breast pump (medela) and pumped a single session with willow.The customer went to the er, was placed on an intravenous antibiotic, hospitalized, and prescribed an oral antibiotic.The customer is completing 3 more days of antibiotics and continues to breast pump with medela.The customer did not report mastitis to medela.

• Brand Name: WILLOW WEARABLE BREAST PUMP
• Common Device Name: POWERED BREAST PUMP
• Manufacturer (Section D): EXPLORAMED NC7, INC.; 1975 w. el camino real; suite 306; mountain view CA 94040
• MDR Report Key: 9120375
• Report Number: 3012759464-2019-00002
• Device Sequence Number: 16622588
• Product Code: HGX
• UDI-Device Identifier: 00858298006293
• UDI-Public: (01)00858298006293(11)190504
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PDW29
• Device Catalogue Number: PDW29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention