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

Model Number 4100018

Device Problem Decrease in Suction (1146)

Patient Problem Unspecified Infection (1930)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

The product involved in the complaint was not returned for evaluation/investigation at this time.An email was sent and 2 phones calls were placed to the customer to request product return.A prepaid (b)(6) return label was provided.No conclusions can be made as to the cause of the event.Should additional information or the original product be received resulting in new or changed information, a follow up report will be filed at that time.

Event Description

Customer contacted ameda, inc.To report an issue with her finesse breast pump.Customer exclusively expresses her breast milk with the finesse pump since baby's birth 3 months ago.She explained that around (b)(6) 2018, the suction dial on the finesse pump had to be held down with pressure to remain powered on or turn up/down.When she released pressure on suction dial, the pump powered off.Customer states the suction pressure overall decreased resulting in decreased milk output.Poorly drained breasts, engorgement and eventually mastitis.She was evaluated by her healthcare provider, diagnosed with mastitis and prescribed oral antibiotics to resolve infection.She began using her manual breast pump until a new finesse pump could be shipped overnight.

• 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.; siute 320; buffalo grove, IL 60089 ; 8478642620
• MDR Report Key: 8176585
• MDR Text Key: 130791031
• Report Number: 3009974348-2018-00330
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725023563
• UDI-Public: (01)00810725023563
• 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: 11/19/2018

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 Number: 4100018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2017
• 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: 28 YR