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

Model Number PDW29

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 03/04/2020

Event Type  Injury  

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 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
• Type of Device: POWERED BREAST PUMP
• Manufacturer (Section D): EXPLORAMED NC7, INC.; 1975 w. el camino real; suite 306; mountain view, ca
• Manufacturer Contact: nelson lam ; 1975 w. el camino real; suite 306; mountain view, ca ; 9898681
• MDR Report Key: 9887172
• MDR Text Key: 196575114
• Report Number: 3012759464-2020-00002
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (Y/N): N
• PMA/PMN Number: K191577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/26/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Device MODEL Number: PDW29
• Device Catalogue Number: PDW29
• Was Device Available For Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 12/27/2019
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 03/26/2020 Patient Sequence Number: 1