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

Model Number	PDW48
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported mastitis which was treated by intravenous therapy and oral antibiotics.A primary cause of mastitis is milk stasis within the breast, providing a medium for bacterial growth.[1,2,3] 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.[1,2,3,4] mastitis is usually a benign, self-limiting condition, with few consequences to the infant and incidence ranging from 4-27%.[5] the willow device has not yet been received by 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.Berens p, abm clinical protocol# 26: persistent pain with breastfeeding.Breastfeed med., 2016;11(2):46-53.
Event or Problem Description
The customer reported to willow customer care on (b)(6) 2020 that she experienced mastitis.Customer visited urgent care and was treated intravenously with an unknown therapy, followed by an oral antibiotic.Customer continued pumping with an alternative breast pump throughout treatment.

• 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: 10623196
• Report Number: 3012759464-2020-00014
• Device Sequence Number: 3232575
• Product Code: HGX
• UDI-Device Identifier: 00858298006446
• UDI-Public: (01)00858298006446(11)200513
• Combination Product (Y/N): N
• PMA/510(K) Number: K191577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PDW48
• Device Catalogue Number: PDW48
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 10/02/2020
• 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: Required Intervention