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

Model Number PDG30

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

Patient Problem Laceration(s) (1946)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported a cut on the nipple which was treated with unknown medication and was healed at 4 days.The willow device was not returned to exploramed nc7 for evaluation, as the customer continued pumping.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 nipple injury.

Event Description

The customer reported to willow customer care on 24-feb-2020 that she experienced a small cut on her right nipple on (b)(6) 2020 from using willow which healed within 4 days.Customer stated that she experiences no pain while pumping.Customer went to doctor and was prescribed a cream.The name of the cream was not provided, and repeated attempts to contact customer for additional information were not answered.

• 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: 10156081
• MDR Text Key: 195563294
• Report Number: 3012759464-2020-00003
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00858298006309
• UDI-Public: (01)00858298006309(11)191205
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PDG30
• Device Catalogue Number: PDG30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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