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

Model Number	PDW29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported a breast abscess which was treated with unknown medication.The willow device has not yet been 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.Based on the information provided, it cannot be definitively concluded that the willow breast pump caused or contributed to the incidence of abscess.The incidence of lactational breast abscess ranges from 0.4 to 11%.Lactational abscesses are due to progression of mastitis or lactational breast inflammation, typically occurring in the first month of breast feeding or at weaning.Predisposing factors include inhibition of gland drainage due to plugged ducts, inadequately managed engorgement, oversupply, or pressure against breast limiting drainage, frequent and effective emptying of the breast is encouraged, either by pumping or manual expression, with the infant feeding restricted to the contralateral side.Benson ea.Management of breast abscesses.World j surg 1989;13:753-6.Scott-conner ceh, schorr sj.The diagnosis and management of breast problems during pregnancy and lactation.Am j surg.1995;170:401-5.Berens pd, breast pain: engorgement, nipple pain, and mastitis.Clin ob and gyn.2015; 58: 4; 902-14.
Event or Problem Description
The customer reported to willow customer care on (b)(6) 2020 that she was admitted to the er multiple times and diagnosed with an abscess on her right breast.The customer was contacted multiple times for additional information, but did not respond.Customer had used willow for multiple sessions.

• Brand Name: WILLOW WEARABLE BREAST PUMP
• Common Device Name: POWERED BREAST PUMP
• Manufacturer (Section D): EXPLORAMED NC7, INC.; 1975 w. el camino real; suite 306; mountain view, ca
• MDR Report Key: 9887172
• Report Number: 3012759464-2020-00002
• Device Sequence Number: 16663626
• Product Code: HGX
• UDI-Device Identifier: 00858298006293
• UDI-Public: (01)00858298006293(11)191227
• Combination Product (Y/N): N
• PMA/510(K) Number: K191577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: No Information
• Device Model Number: PDW29
• Device Catalogue Number: PDW29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/26/2020
• 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