MAUDE Adverse Event Report: CHIARO TECHNOLOGY LTD. ELVIE DOUBLE BREAST PUMP; PUMP, BREAST, POWERED

Model Number	EP01
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
I got an elvie double.One of the elvie pumps makes a clicking noise.I contacted the manufacturer as product is still under warranty.The manufacturer refused to follow up and investigate and assist in resolving matter and kept closing the complaint within days.Fda safety report id # (b)(4).
Event or Problem Description
I got an elvie double.One of the elvie pumps makes a clicking noise.I contacted the manufacturer as product is still under warranty.The manufacturer refused to follow up and investigate and assist in resolving matter and kept closing the complaint within days.Fda safety report id # (b)(4).

• Brand Name: ELVIE DOUBLE BREAST PUMP
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): CHIARO TECHNOLOGY LTD.
• MDR Report Key: 13592290
• Report Number: MW5107676
• Device Sequence Number: 12071320
• Product Code: HGX
• UDI-Device Identifier: 05060442520035
• UDI-Public: (01)05060442520035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: EP01
• Device Catalogue Number: EP01-02-M
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2022
• Patient Sequence Number: 1
• Patient Sex: Female