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U.S. Department of Health and Human Services

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

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EXPLORAMED NC7, INC. WILLOW BREAST PUMP; POWERED BREAST PUMP Back to Search Results
Model Number PDG01
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 04/18/2018
Event Type  Injury  
Manufacturer Narrative
Prior to the initial diagnosis of mastitis, the customer used willow and a spectra breast pump.After the initial diagnosis of mastitis (reported april 23, 2018), she discontinued use with the willow breast pump and used the spectra breast pump exclusively and continued to breast feed.The pumps have not been returned to exploramed nc7 for evaluation but a manufacturing review was conducted on the device history record and no nonconformances were noted in the production of these devices.With 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 for the suckling infant.In worldwide studies published within the last 20 years, the incidence of lactation mastitis ranged from 4% to 27%." wambach, karen, and jan riordan.Breastfeeding and human lactation.5th ed., jones & bartlett learning, 2016.
 
Event Description
On (b)(6) 2018, the customer reported to willow customer care that on (b)(6) 2018 she had a fever and went to see her physician.Her physician diagnosed her with mastitis and prescribed oral antibiotics as treatment.On (b)(6) 2018, 28 days after the initial onset of mastitis, the customer replied to earlier follow-up attempts by willow customer care and she reported that the initial prescription of antibiotic medication had been ineffective in improving her condition.She was admitted and placed on an intravenous antibiotic from (b)(6) 2018.The mastitis has since resolved and the customer continues to breast feed and breast pump.
 
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Brand Name
WILLOW BREAST PUMP
Type of Device
POWERED BREAST PUMP
Manufacturer (Section D)
EXPLORAMED NC7, INC.
201 san antonio circle
suite 172
mountain view CA 94040 1255
Manufacturer Contact
keri ng
201 san antonio circle
suite 172
mountain view, CA 94040-1255
MDR Report Key7538212
MDR Text Key109054281
Report Number3012759464-2018-00008
Device Sequence Number1
Product Code HGX
UDI-Device Identifier00858298006019
UDI-Public(01)00858298006019(11)251217
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberPDG01
Device Catalogue NumberPDG01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/23/2018
Initial Date FDA Received05/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/25/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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