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

Model Number	PDG30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer reported to willow customer care that on (b)(6) 2019 that she was diagnosed with mastitis.The customer reported that she was hospitalized for 7 days and prescribed three types of antibiotics.She was placed on an intravenous antibiotic (cleocine) and an oral antibiotic (linezolid).Information on the third antibiotic was not provided.The customer reported that she was pumping with willow and another breast pump (spectra) during the time of the reported mastitis.The mastitis has since resolved, and the customer continues to breast pump.

• Brand Name: WILLOW 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: 8972911
• Report Number: 3012759464-2019-00001
• Device Sequence Number: 2563096
• Product Code: HGX
• UDI-Device Identifier: 00858298006309
• UDI-Public: (01)00858298006309(11)190328
• Combination Product (Y/N): N
• 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): 08/27/2019

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: PDG30
• Device Catalogue Number: PDG30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 09/06/2019
• 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