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

Model Number 4100018

Device Problem Suction Problem (2170)

Patient Problem Unspecified Infection (1930)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

The returned pump (finesse) was evaluated for evidence of allegation.The returned pump met ameda specifications for both suction and speed, and passed visual inspection standards.No evidence of malfunction was observed.

Event Description

Customer contacted ameda, inc.On (b)(6) 2018 to report her finesse breast pump, that she uses exclusively to express her breast milk, would not power on using either the ac adapter or batteries.This event occurred late in the day on (b)(6) 2018.She reports using a very old pump she still had from a previous child which did not work effectively.Customer states that by morning she had general symptoms of mastitis; fever, chills, swollen and sore left breast.She was prescribed a 10 day course of oral antibiotics.Customer was shipped a replacement breast pump overnight for effective pumping to continue.Customer states feeling an improvement within 2 days.

• 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 ; 8479642620
• MDR Report Key: 7584754
• MDR Text Key: 110574641
• Report Number: 3009974348-2018-00319
• 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: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4100018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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 Outcome(s): Other
• Patient Age: 38 YR