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

Model Number	PDW48
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported thrush which was treated by a doctor prescribed topical antibiotic medication.Thrush is caused by a yeast fungus.Yeast grows in moist, warm environments.Risk of developing thrush can be increased by recent course of antibiotics1, cracked or damaged nipples1, oral contraceptives or steroids clothing not designed for breastfeeding that traps moisture2, and hot, humid conditions.The willow device was not 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 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 or Problem Description
The customer reported to willow customer care on 02 oct 2020 that she had been diagnosed with thrush by her doctor and received a prescription compounded nipple ointment containing betamethasone, miconazole, mupirocin, and in addition, gentian violet.

• 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 94040
• MDR Report Key: 10857099
• Report Number: 3012759464-2020-00016
• Device Sequence Number: 19554517
• Product Code: HGX
• UDI-Device Identifier: 00858298006446
• UDI-Public: (01)00858298006446(11)200203
• Combination Product (Y/N): N
• PMA/510(K) Number: K191577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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: Lay User/Patient
• Device Model Number: PDW48
• Device Catalogue Number: PDW48
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 11/17/2020
• 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