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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 Unspecified Infection (1930)
Event Date 08/30/2019
Event Type  Injury  
Manufacturer Narrative

The customer is an exclusive pumper (pumps but does not breastfeed). During the week prior to the reported mastitis, customer reported that she was pumping with another breast pump (medela) and only pumped once with willow. 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 incident of mastitis. Mastitis is usually a benign, self-limiting condition, with few consequences to the infant and incidence ranging from 4-27%. [1] a primary cause of mastitis is milk stasis within the breast, providing a medium for bacterial growth. [2,3,4] 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. [2,3,4,5] 1. Wambach, karen, and jan riordan. Breastfeeding and human lactation. 5th ed. , jones & bartlett learning, 2016. 2. World health organization, mastitis causes & management, 2002. 3. Spencer jp, management of mastitis in breastfeeding women, american family physician. 2008; 78 (6): 727-732. 4. Michie c, the challenge of mastitis. Arch dis child. 2003: 88, 818-821. 5. Foxman b, lactation mastitis: occurrence and medical management among 946 breastfeeding women in the united states. Am j epidemiol, 155 (2) 2002.

 
Event Description

The customer reported to willow customer care that on (b)(6) 2019 she was treated for mastitis. The customer reported that during the week preceding the reported mastitis, she was pumping with another breast pump (medela) and pumped a single session with willow. The customer went to the er, was placed on an intravenous antibiotic, hospitalized, and prescribed an oral antibiotic. The customer is completing 3 more days of antibiotics and continues to breast pump with medela. The customer did not report mastitis to medela.

 
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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 94040
Manufacturer Contact
john chang
1975 w. el camino real
suite 306
mountain view, 
MDR Report Key9120375
MDR Text Key163338407
Report Number3012759464-2019-00002
Device Sequence Number1
Product Code HGX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK161266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 09/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2019
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberPDW29
Device Catalogue NumberPDW29
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/04/2019
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: 09/25/2019 Patient Sequence Number: 1
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