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

Model Number PDW48

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

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported mastitis which was treated by prescribed antibiotics.A primary cause of mastitis is milk stasis within the breast, providing a medium for bacterial growth.There are a variety of risk factors for mastitis, including missed or restricted feedings, breast engorgement, restriction from tight bra/ clothing, prone sleeping position, maternal stress, excessive fatigue, and malnutrition.Mastitis is usually a benign, self-limiting condition, with few consequences to the infant and incidence ranging from 4-27%.Blisters on the nipple/ breast can be caused by frequent breastfeeding with friction due to improper latch, improper sizing of the flange, or malalignment within the flange.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 wearable breast pump caused or contributed to the incident of mastitis and blister.World health organization, mastitis causes & management, 2002.Spencer jp, management of mastitis in breastfeeding women, american family physician.2008; 78 (6): 727-732.Michie c, the challenge of mastitis.Arch dis child.2003: 88, 818-821.Foxman b, lactation mastitis: occurrence and medical management among 946 breastfeeding women in the united states.Am j epidemiol, 155 (2) 2002.Wambach, karen, and jan riordan.Breastfeeding and human lactation.5th ed., jones & bartlett learning, 2016.Berens p, abm clinical protocol# 26: persistent pain with breastfeeding.Breastfeed med., 2016;11(2):46-53.

Event Description

The customer reported to (b)(6) customer care on 24 jun 2020 that she had gone to the hospital twice and was prescribed antibiotics for mastitis.Customer also reported that she developed a blister on her nipple and was prescribed a topical medication.

• 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: 10324181
• MDR Text Key: 200801417
• Report Number: 3012759464-2020-00009
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00858298006446
• UDI-Public: (01)00858298006446(11)190824
• 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: 07/24/2020

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
• Device Operator: No Information
• Device Model Number: PDW48
• Device Catalogue Number: PDW48
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention