MAUDE Adverse Event Report: MEDELA AG FS HANDS-FREE PUMP PT-A EN ES FR; PUMP, BREAST, POWERED

Model Number	101044164
Medical Device Problem Codes	Suction Problem (2170); Power Problem (3010)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including verifying correct kit components were being used, washed and dried according to our instructions for use; verifying no milk backup occurred; and reset the battery and requested it be charged.The troubleshooting did not resolve the issue.A replacement device was sent to the customer and return of her original pump was requested for testing/evaluation.The customer was contacted by a complaint handler on multiple occasions to get additional information, with no response as of the date of this report.Based on the results of our internal investigation (reference number (b)(4)), it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is (b)(4)% for the period of january 2013 to august 2017.Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However, in this case, the mother¿s mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On (b)(6) 2023, the customer alleged to medela llc that her freestyle hands-free breast pump turns off and the pump speed goes up and down on its own.Additionally, the customer alleged that she developed mastitis and was prescribed an antibiotic.

• Brand Name: FS HANDS-FREE PUMP PT-A EN ES FR
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 18100007
• Report Number: 3002807523-2023-00017
• Device Sequence Number: 12151661
• Product Code: HGX
• UDI-Device Identifier: 00020451441641
• UDI-Public: 020451441641
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 101044164
• Device Catalogue Number: 101044164
• Device Lot Number: 0000564311
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female