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

Catalog Number	PDW00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Subsequent follow-up communication with the user shows that she continues to use willow and has not had a reoccurrence of mastitis.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.In worldwide studies published within the last 20 years, the incidence of lactation mastitis ranged from 4% to 27%." wambach, karen, and jan riordan.Breastfeeding and human lactation.5th ed., jones & bartlett learning, 2016.
Event or Problem Description
While in communication with the customer on (b)(6) 2018, the customer reported that she had mastitis and was prescribed antibiotics but was continuing to pump with willow.

• Brand Name: WILLOW BREAST PUMP
• Common Device Name: POWERED BREAST PUMP
• Manufacturer (Section D): EXPLORAMED NC7, INC.; 201 san antonio circle; suite 172; mountain view CA 94040 1255
• MDR Report Key: 7557747
• Report Number: 3012759464-2018-00010
• Device Sequence Number: 13511138
• Product Code: HGX
• UDI-Device Identifier: 00858298006002
• UDI-Public: (01)00858298006002(11)170921
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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 Catalogue Number: PDW00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/31/2018
• 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