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

Catalog Number	PDW00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In (b)(6) 2018, the user informed customer service that she also uses another breast pump and she uses a 21mm flange with it.With willow, the user utilizes a 24mm flange and she indicated to customer service that she thought it may have been the wrong flange size for her anatomy.On february 21, 2018, the customer returned the device to exploramed nc7.Investigation was performed on the device and it was found to meet specification.Based on the results of the investigation on the returned device, 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 allegedly developed mastitis while using willow.On (b)(6) 2018, she reported that she was prescribed antibiotics for her mastitis and the mastitis was resolved.

• Brand Name: WILLOW WEARABLE 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: 7304944
• Report Number: 3012759464-2018-00001
• Device Sequence Number: 1483811
• Product Code: HGX
• UDI-Device Identifier: 00858298006002
• UDI-Public: (01)00858298006002(11)171108
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/02/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/28/2018
• 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