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

Model Number	PDG01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 7538212
• Report Number: 3012759464-2018-00008
• Device Sequence Number: 16568736
• Product Code: HGX
• UDI-Device Identifier: 00858298006019
• UDI-Public: (01)00858298006019(11)251217
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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
• Operator of Device: Lay User/Patient
• Device Model Number: PDG01
• Device Catalogue Number: PDG01
• 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: 04/23/2018
• Initial Report FDA Received Date: 05/23/2018
• 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: Hospitalization; Required Intervention