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

Model Number	PDW50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported a cut on the nipple which was treated with a prescribed topical cream.The flange size may not have been appropriate, as customer had not sized per the instructions for use.Customer continued to pump and breastfeed throughout.The device has not yet been returned to exploramed nc7 for evaluation.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 or Problem Description
The customer reported to willow customer care on 20 jul 2020 that she experienced a cut on her nipple.She was prescribed a topical cream.Customer continues to pump and breastfeed.

• 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
• MDR Report Key: 10429229
• Report Number: 3012759464-2020-00011
• Device Sequence Number: 2939564
• Product Code: HGX
• UDI-Device Identifier: 00858298006484
• UDI-Public: (01)00858298006484(11)200410
• 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): 08/19/2020

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: PDW50
• Device Catalogue Number: PDW50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/19/2020
• 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