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

Model Number	PDW48
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported mastitis and sepsis which was treated by doctor visit and medication.The customer continued to pump.The initiating factor in this situation, mastitis, is primarily caused by milk stasis within the breast, providing a medium for bacterial growth.1,2,3 there are a variety of risk factors for mastitis, including missed or restricted feedings, breast engorgement, restriction from tight bra/ clothing, prone sleeping position, maternal stress, excessive fatigue, and malnutrition.1,2,3,4 mastitis is usually a benign, self-limiting condition, with few consequences to the infant and incidence ranging from 4-27%.5 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 incident of mastitis.World health organization, mastitis causes & management, 2002.Spencer jp, management of mastitis in breastfeeding women, american family physician.2008; 78 (6): 727-732.Michie c, the challenge of mastitis.Arch dis child.2003: 88, 818-821.Foxman b, lactation mastitis: occurrence and medical management among 946 breastfeeding women in the united states.Am j epidemiol, 155 (2) 2002.Wambach, karen, and jan riordan.Breastfeeding and human lactation.5th ed., jones & bartlett learning, 2016.
Event or Problem Description
On (b)(6) 2022, the customer reported to willow customer care that she had visited her doctor for mastitis (initiated (b)(6)) which led to sepsis.The doctor recommended she use another pump to empty her breasts.The customer did not respond to follow up regarding medications prescribed or treatment given, but stated that "the medication has cut her milk supply." customer stated that she would continue using the pump until she received another pump from her insurance.

• 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; mountain view CA 94040
• Manufacturer Contact: nelson lam ; 1975 w. el camino real; suite 306; mountain view, CA 94040 ; 9259898681
• MDR Report Key: 13387038
• Report Number: 3012759464-2022-00001
• Device Sequence Number: 5415990
• 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): 01/28/2022

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: PDW48
• Device Catalogue Number: PDW48
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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