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

Model Number	PDW29
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	01/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer reported development of an areolar abscess.Customer was treated with unknown medications.It is unclear if the abscess occurred before or after her use of willow which was received (b)(6) 2022.Visual inspection on the pump found fluid ingress with fluid residue on the flex circuit board of the pump which has the potential to cause functional issues.However, vacuum profile testing of the returned pump found the pump functioning as intended.The vacuum profile of the pump is within specifications, and pumping simulation was also performed with no issues found.Additionally, 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 incidence of abscess.
Event or Problem Description
On (b)(6) 2022, customer reported to willow customer care that she developed an abscess on her areola (date of occurrence is after (b)(6) 2022).It is unclear whether or not she was using her willow pump during the time the abscess developed.As of (b)(6)2022, customer's abscess had not fully healed.

• 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: 13831689
• Report Number: 3012759464-2022-00003
• Device Sequence Number: 16391417
• Product Code: HGX
• UDI-Device Identifier: 00858298006293
• UDI-Public: (01)00858298006293(11)220112
• 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): 03/21/2022

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: PDW29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female