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 Code	Skin Tears (2516)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported a tear on the nipple which was treated with a prescribed topical steroid cream.The customer continued to pump.The device was not returned to exploramed nc7 for evaluation.Based on the information provided, it cannot be definitively concluded that the willow breast pump caused or contributed to the nipple injury.
Event or Problem Description
The customer reported to (b)(6) customer care on (b)(6) 2020 that she experienced a tear on her nipple.The customer's ob/ gyn prescribed a topical steroid cream.The customer reported pumping as she healed.

• 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: 10857026
• Report Number: 3012759464-2020-00019
• Device Sequence Number: 2885338
• Product Code: HGX
• UDI-Device Identifier: 00858298006446
• UDI-Public: (01)00858298006446(11)200622
• 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): 11/17/2020

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: 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: 10/19/2020
• Initial Report FDA Received Date: 11/17/2020
• 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