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 Problem Unspecified Infection (1930)

Event Date 11/24/2019

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%.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.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.

Event Description

The customer reported to willow customer care on 27 dec 2019 that willow was not emptying her breasts fully and she had developed mastitis and was treated with antibiotics.The customer reported that she went to the emergency room multiple times ((b)(6) 2019 and (b)(6) 2019) and that one of her antibiotic treatments caused anaphylaxis.

• 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: 10319493
• MDR Text Key: 203675186
• Report Number: 3012759464-2020-00008
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00858298006446
• UDI-Public: (01)00858298006446(11)200130
• 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

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PDW48
• Device Catalogue Number: PDW48
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• 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): Required Intervention