MAUDE Adverse Event Report: AMEDA, INC. FINESSE; ELECTRIC BREAST PUMP

Model Number 4100018

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

The product involved in the complaint was not returned for evaluation/investigation at this time.The customer was phoned four times and emailed twice in an attempt to retrieve the product.Should additional information or the original product be received resulting in new, changed or corrected information, a follow up report will be filed at that time.

Event Description

Customer contacted ameda, inc.On (b)(4) 2019 to report an incident that occurred on (b)(6) 2019 after she used the finesse breast pump.She states she completed pumping and exited the room, leaving the ac adapter plugged into the electrical outlet.Her sister found the ac adapter melted after seeing smoke coming from the electrical outlet it was plugged into.Customer reports no injury in this event.She was overnight shipped a finesse breast pump and ac adapter.

• Brand Name: FINESSE
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC.; 485 half day rd.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8478642620
• MDR Report Key: 8312817
• MDR Text Key: 135233958
• Report Number: 3009974348-2019-00334
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725023563
• UDI-Public: (01)00810725023563(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4100018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR