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

Model Number	PDG01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported blisters which were treated by topical antibiotics.Blisters on the nipple/ breast can be caused by frequent breastfeeding with friction [1] due to improper latch, improper sizing of the flange, or malalignment within the flange.The willow device was not returned to exploramed nc7 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 blister.Berens p, abm clinical protocol# 26: persistent pain with breastfeeding.Breastfeed med., 2016;11(2):46-53.
Event or Problem Description
The customer reported to willow customer care on (b)(6) 2020 that she was experiencing blood blisters.Customer spoke to her ob/gyn and was prescribed a topical antibiotic (gentamicin sulfate ointment usp.1%) to prevent infection and help the skin heal faster.

• 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: 10783379
• Report Number: 3012759464-2020-00017
• Device Sequence Number: 11711910
• Product Code: HGX
• UDI-Device Identifier: 00858298006019
• UDI-Public: (01)00858298006019(11)190722
• 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): 11/03/2020

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: Lay User/Patient
• Device Model Number: PDG01
• Device Catalogue Number: PDG01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 11/04/2020
• 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