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	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the time period in which the mastitis occurred, the user was also pumping with another breast pump three times a day.She reported that she used the willow breast pump for a total of two times when she developed mastitis.The user discontinued use of the willow breast pump after this incident.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.According to a report by the world health organization from 2000 titled, "mastitis: causes and management," "the reported incidence [of mastitis] varies from a few to 33% of lactating women, but is usually under 10%.".
Event or Problem Description
On (b)(6) 2018, the customer reported to exploramed nc7 that she had developed mastitis while using willow.The manufacturer contacted the user, and on (b)(6) 2018, the manufacturer learned that the mastitis occurred in (b)(6) 2017.The user was prescribed antibiotics for her mastitis, which has since resolved.

• 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: 7339606
• Report Number: 3012759464-2018-00002
• Device Sequence Number: 13682407
• Product Code: HGX
• UDI-Device Identifier: 00858298006002
• UDI-Public: (01)00858298006002(11)170913
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/14/2018

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: 02/14/2018
• Initial Report FDA Received Date: 03/14/2018
• 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