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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 PDG30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 02/20/2020
Event Type  Injury  
Manufacturer Narrative

The customer reported a cut on the nipple which was treated with unknown medication and was healed at 4 days. The willow device was not returned to exploramed nc7 for evaluation, as the customer continued pumping. 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 nipple injury.

 
Event Description

The customer reported to willow customer care on 24-feb-2020 that she experienced a small cut on her right nipple on (b)(6) 2020 from using willow which healed within 4 days. Customer stated that she experiences no pain while pumping. Customer went to doctor and was prescribed a cream. The name of the cream was not provided, and repeated attempts to contact customer for additional information were not answered.

 
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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 Key10156081
MDR Text Key195563294
Report Number3012759464-2020-00003
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 06/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberPDG30
Device Catalogue NumberPDG30
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/05/2019
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: 06/15/2020 Patient Sequence Number: 1
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