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

Catalog Number PDW00

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/03/2018

Event Type  Injury  

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 Description

While in communication with the customer on (b)(6) 2018, the customer reported that she had mastitis in her left breast and was prescribed antibiotics but was continuing to pump with willow.

• Brand Name: WILLOW BREAST PUMP
• Type of Device: POWERED BREAST PUMP
• Manufacturer (Section D): EXPLORAMED NC7, INC.; 201 san antonio circle; suite 172; mountain view CA 94040 1255
• Manufacturer Contact: keri ng ; 201 san antonio circle; suite 172; mountain view, CA 94040-1255
• MDR Report Key: 7557827
• MDR Text Key: 109741811
• Report Number: 3012759464-2018-00009
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00858298006002
• UDI-Public: (01)00858298006002(11)170927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PDW00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention