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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 PDW29
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abscess (1690)
Event Date 03/04/2020
Event Type  Injury  
Manufacturer Narrative

The customer reported a breast abscess which was treated with unknown medication. The willow device has not yet been 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 breast pump caused or contributed to the incidence of abscess. The incidence of lactational breast abscess ranges from 0. 4 to 11%. Lactational abscesses are due to progression of mastitis or lactational breast inflammation, typically occurring in the first month of breast feeding or at weaning. Predisposing factors include inhibition of gland drainage due to plugged ducts, inadequately managed engorgement, oversupply, or pressure against breast limiting drainage, frequent and effective emptying of the breast is encouraged, either by pumping or manual expression, with the infant feeding restricted to the contralateral side. Benson ea. Management of breast abscesses. World j surg 1989;13:753-6. Scott-conner ceh, schorr sj. The diagnosis and management of breast problems during pregnancy and lactation. Am j surg. 1995;170:401-5. Berens pd, breast pain: engorgement, nipple pain, and mastitis. Clin ob and gyn. 2015; 58: 4; 902-14.

 
Event Description

The customer reported to willow customer care on (b)(6) 2020 that she was admitted to the er multiple times and diagnosed with an abscess on her right breast. The customer was contacted multiple times for additional information, but did not respond. Customer had used willow for multiple sessions.

 
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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, ca
Manufacturer Contact
nelson lam
1975 w. el camino real
suite 306
mountain view, ca 
9898681
MDR Report Key9887172
MDR Text Key196575114
Report Number3012759464-2020-00002
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 03/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberPDW29
Device Catalogue NumberPDW29
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/27/2019
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: 03/26/2020 Patient Sequence Number: 1
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