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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, PRODUCT CODE

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EXPLORAMED NC7, INC. WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP, PRODUCT CODE 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 12/19/2019
Event Type  Injury  
Manufacturer Narrative

The customer reported mastitis which was treated by doctor prescribed iv antibiotics. 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]. Wambach, karen, and jan riordan. Breastfeeding and human lactation. 5th ed. , jones & bartlett learning, 2016. World health organization, mastitis causes & management, 2002. Spencer jp, management of mastitis in breastfeeding women, american family physician. 2008; 78 (6): 727-732. Michie c, the challenge of mastitis. Arch dis child. 2003: 88, 818-821. 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 on (b)(6) 2019 that she was treated for mastitis. She was treated by her physician with intravenous antibiotics. The customer had been using willow for at least 3 days prior to the condition developing and continued to use willow for several days afterward. She continued pumping with an alternate pump throughout treatment.

 
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Brand NameWILLOW WEARABLE BREAST PUMP
Type of DevicePOWERED BREAST PUMP, PRODUCT CODE
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, CA 94040
6505753465
MDR Report Key9614298
MDR Text Key176957663
Report Number3012759464-2020-00001
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 01/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberPDW29
Device Catalogue NumberPDW29
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/21/2020 Patient Sequence Number: 1
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