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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 Problems Unspecified Infection (1930); Injury (2348)
Event Date 05/15/2020
Event Type  Injury  
Manufacturer Narrative

The customer reported mastitis which was treated by prescribed antibiotics. A primary cause of mastitis is milk stasis within the breast, providing a medium for bacterial growth. 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. Mastitis is usually a benign, self-limiting condition, with few consequences to the infant and incidence ranging from 4-27%. Blisters on the nipple/ breast can be caused by frequent breastfeeding with friction due to improper latch, improper sizing of the flange, or malalignment within the flange. 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 wearable breast pump caused or contributed to the incident of mastitis and blister. 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. Wambach, karen, and jan riordan. Breastfeeding and human lactation. 5th ed. , jones & bartlett learning, 2016. Berens p, abm clinical protocol# 26: persistent pain with breastfeeding. Breastfeed med. , 2016;11(2):46-53.

 
Event Description

The customer reported to (b)(6) customer care on 24 jun 2020 that she had gone to the hospital twice and was prescribed antibiotics for mastitis. Customer also reported that she developed a blister on her nipple and was prescribed a topical medication.

 
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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 Key10324181
MDR Text Key200801417
Report Number3012759464-2020-00009
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 07/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2020
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 Received06/24/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/24/2019
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: 07/24/2020 Patient Sequence Number: 1
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