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 06/06/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported thrush which was treated by a doctor prescribed antifungal medication.Thrush is caused by a yeast fungus.1 yeast grows in moist, warm environments.Risk of developing thrush can be increased by recent course of antibiotics 1, cracked or damaged nipples 1, oral contraceptives or steroids 1, clothing not designed for breastfeeding that traps moisture, 2, and hot, humid conditions, 2.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 nonconformance's 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 this incident of thrush.La leche league international, https://www.Llli.Org/breastfeeding-info/thrush/.Healthline, nipple thrush and breastfeeding, https://www.Healthline.Com/health/nipple-thrush # takeaway.

Event Description

The customer reported to willow customer care on (b)(6) 2020 that she had been diagnosed with thrush from a lactation specialist and then received prescription antifungal from her ob/gyn.She took a 14 day oral dose of fluconazole and a topical antifungal cream.

• 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,
• Manufacturer Contact: nelson lam ; 1975 w. el camino real; suite 306; mountain view, ca ; 9898681
• MDR Report Key: 10312942
• MDR Text Key: 203703188
• Report Number: 3012759464-2020-00007
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00858298006446
• UDI-Public: (01)00858298006446(11)200415
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2020
• 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