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

Model Number	PDW48
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported breast irritation which was treated with oral antibiotics.The willow device was not returned to exploramed nc7 for evaluation, as the customer continues to pump with willow.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 irritation.
Event or Problem Description
The customer reported to willow customer care on (b)(6) 2020 that she experienced extreme discomfort and excessive pinching when using willow containers.Customer sought medical advice first via telephone, due to covid 19, and was first prescribed a compounded ointment, then antibiotics.After a week of no relief, she visited the doctor's office and was told she had irritation due to the pump.The customer continued to pump with willow both during and after treatment.

• 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,
• MDR Report Key: 10193216
• Report Number: 3012759464-2020-00004
• Device Sequence Number: 3017981
• Product Code: HGX
• UDI-Device Identifier: 00858298006446
• UDI-Public: (01)00858298006446(11)200211
• Combination Product (Y/N): N
• PMA/510(K) Number: K191577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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
• Operator of Device: No Information
• 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: 05/26/2020
• Initial Report FDA Received Date: 06/24/2020
• 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