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

Model Number	PDW48
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Sepsis (2067); Kidney Infection (4502); Skin Infection (4544)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported hospitalization for mastitis, sepsis, and pyelonephritis which was treated by intravenous and oral antibiotics: vancomycin, meropenem, clindamycin, keflex, and vantin.The etiology of the sepsis is unclear, but is more likely due to the pyelonephritis.The willow device has not yet been received by exploramed nc7.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 incidence of infection.
Event or Problem Description
On 7/15/2021, the customer reported to willow customer care that she had been seen by a nurse practitioner and prescribed oral antibiotics (dynapen) on (b)(6) 2021.She was seen by an ob/ gyn on (b)(6) 2021 and admitted to the hospital.Her diagnosis was mastitis, sepsis, and pyelonephritis.While in the hospital, she was given iv antibiotics (vancomycin, meropenem, and clindamycin).Upon release, she was prescribed oral keflex and vantin.Customer was not able to breastfeed, hand express, or pump.Customer has healed, but has thickened breast tissue which requires follow-up with a mammogram.

• 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 94040
• MDR Report Key: 12235711
• Report Number: 3012759464-2021-00002
• Device Sequence Number: 4157854
• Product Code: HGX
• UDI-Device Identifier: 00858298006446
• UDI-Public: (01)00858298006446(11)210329
• 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): 07/26/2021

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: 07/15/2021
• Initial Report FDA Received Date: 07/27/2021
• 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: Hospitalization; Required Intervention