MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS-FREE EN ES FR - US ADAPTER; PUMP, BREAST, POWERED

Model Number	101044164
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025 , the customer alleged to medela llc that she was having issues with her tubing for her freestyle breast pump.She additionally alleged that the pump was having power issues, and she developed mastitis and was treated with medication.
Additional Manufacturer Narrative
Customer service sent the customer a new breast pump and cups.In follow up with a complaint handler on (b)(6) 2025, the customer indicated that she developed mastitis on (b)(6) 2025 and went to the doctor the next day was prescribed an antibiotic after having a fever for 24 hours.She indicated that the replacement pump was working without issue and her mastitis was resolved.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 0.008% 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.

• Brand Name: FREESTYLE HANDS-FREE EN ES FR - US ADAPTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lättichstrasse 4b; baar zug 6340 ; SZ 6340
• Manufacturer (Section G): MEDELA AG; lättichstrasse 4b; baar zug 6340 ; SZ 6340
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 21734596
• Report Number: 1419937-2025-00002
• Device Sequence Number: 14508843
• Product Code: HGX
• UDI-Device Identifier: 00020451441641
• UDI-Public: 00020451441641
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/31/2025

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: 0000715368
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/31/2025
• Date Device Manufactured: 08/27/2024
• 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