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

Model Number PDG01

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Prior to the initial diagnosis of mastitis, the customer used willow and a spectra breast pump.After the initial diagnosis of mastitis (reported april 23, 2018), she discontinued use with the willow breast pump and used the spectra breast pump exclusively and continued to breast feed.The pumps have not been returned to exploramed nc7 for evaluation but a manufacturing review was conducted on the device history record and no nonconformances were noted in the production of these devices.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

On (b)(6) 2018, the customer reported to willow customer care that on (b)(6) 2018 she had a fever and went to see her physician.Her physician diagnosed her with mastitis and prescribed oral antibiotics as treatment.On (b)(6) 2018, 28 days after the initial onset of mastitis, the customer replied to earlier follow-up attempts by willow customer care and she reported that the initial prescription of antibiotic medication had been ineffective in improving her condition.She was admitted and placed on an intravenous antibiotic from (b)(6) 2018.The mastitis has since resolved and the customer continues to breast feed and breast pump.

• 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: 7538212
• MDR Text Key: 109054281
• Report Number: 3012759464-2018-00008
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00858298006019
• UDI-Public: (01)00858298006019(11)251217
• 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
• Type of Report: Initial
• Report Date: 04/23/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: PDG01
• Device Catalogue Number: PDG01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/25/2017
• 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): Hospitalization; Required Intervention