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U.S. Department of Health and Human Services

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

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EXPLORAMED NC7, INC WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP Back to Search Results
Model Number PDW48
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 05/26/2020
Event Type  Injury  
Manufacturer Narrative

The customer reported breast irritation which was treated with oral antibiotics. The willow device was not returned to exploramed nc7 for evaluation, as the customer continues to pump with willow. 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 breast pump caused or contributed to the incidence of irritation.

 
Event Description

The customer reported to willow customer care on (b)(6) 2020 that she experienced extreme discomfort and excessive pinching when using willow containers. Customer sought medical advice first via telephone, due to covid 19, and was first prescribed a compounded ointment, then antibiotics. After a week of no relief, she visited the doctor's office and was told she had irritation due to the pump. The customer continued to pump with willow both during and after treatment.

 
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Brand NameWILLOW WEARABLE BREAST PUMP
Type of DevicePOWERED BREAST PUMP
Manufacturer (Section D)
EXPLORAMED NC7, INC
1975 w. el camino real
suite 306
mountain view,
Manufacturer Contact
nelson lam
1975 w. el camino real
suite 306
mountain view, ca 
9898681
MDR Report Key10193216
MDR Text Key196404643
Report Number3012759464-2020-00004
Device Sequence Number1
Product Code HGX
Combination Product (Y/N)N
PMA/PMN NumberK191577
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 06/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberPDW48
Device Catalogue NumberPDW48
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/11/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/24/2020 Patient Sequence Number: 1
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