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

Model Number	PRW31
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Skin Tears (2516); Skin Infection (4544)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the customer reported to willow customer care that on (b)(6) 2021 she had experienced injury to her nipple tissue.Her ob/gyn prescribed oral antibiotics due to infection (2 rounds).Customer stated that she would no longer be able to bf, and may need to have corrective surgery.Customer stated that her initial injury healed, although not properly.After the injury, she stated that she was still pumping, using one pump.No further follow up was provided.
Additional Manufacturer Narrative
The customer reported injury to her nipple tissue and infection which was treated by doctor visit and oral antibiotics.The customer reported that she was not able to breastfeed on the injured breast.The device has not been returned to willow innovations, inc.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 wearable breast pump caused or contributed to the injury to nipple tissue.

• Brand Name: WILLOW WEARABLE BREAST PUMP
• Common Device Name: POWERED BREAST PUMP
• Manufacturer (Section D): WILLOW INNOVATIONS, INC.; 1975 w. el camino real; suite 306; mountian view CA 94040
• Manufacturer Contact: nelson lam ; 1975 w. el camino real; suite 306; mountain view, CA 94040 ; 9259898681
• MDR Report Key: 13831801
• Report Number: 3012759464-2022-00002
• Device Sequence Number: 19060215
• Product Code: HGX
• UDI-Device Identifier: 00858298006187
• UDI-Public: (01)00858298006187(11)211029
• 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): 02/18/2022

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
• Device Model Number: PRW31
• Device Catalogue Number: PRW31
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female