MAUDE Adverse Event Report: EXPLORAMED NC7, INC. WILLOW 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	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018, the user was pumping with willow and during her session, she reported falling asleep and had the pump latched for about an hour before waking up.She reported blisters on her nipples after this pumping session.The willow instructions for use states, "only wear willow (latched) while pumping." the user continued to hand express and pump with another commercial breast pump.The user's physician assessed that the user's mastitis was a result of her nipple swelling, which prevented her from emptying her breasts; however, the physician could not determine if it was a direct result from pumping with willow.Exploramed nc7 received the product for evaluation on march 27, 2018, and testing of the pumps concluded that both units meet specification and function as intended.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."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
During communication with the customer on (b)(4) 2018, the customer stated that her lactation consultant recommended that she see her physician as she felt she was in the beginning stages of mastitis.The physician prescribed her antibiotics as treatment 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: 7430670
• Report Number: 3012759464-2018-00004
• Device Sequence Number: 1963032
• Product Code: HGX
• UDI-Device Identifier: 00858298006002
• UDI-Public: (01)00858298006002(11)170920
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/02/2018

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: 03/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 04/13/2018
• 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