MAUDE Adverse Event Report: Medela AG Freestyle Hands-free EN ES FR; Pump, Breast, Powered

Model Number	101044164
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the customer contacted medela llc that while using the freestyle hands-free she was diagnosed with mastitis due to poor or insufficient suction.Additionally, on (b)(6) 2026 she alleged that she was prescribed antibiotics.
Additional Manufacturer Narrative
Customer service sent a replacement pump to the customer and asked for the return of her old pump for evaluation.In follow up with a complaint handler on (b)(6) 2026, the customer stated that she was sent a replacement pump and she had sent her pump in for evaluation.Additionally, the customer stated she had developed mastitis requiring antibiotics approximately one month before contacting medela.On (b)(6) 2026, the pump was evaluated and tested within normal operating range the customers complaint was unable to be duplicated.Based on the results of our internal investigation (capa-2025-0027) including published literature, it cannot definitively be concluded that the pump caused or has contributed to the customer's reported mastitis.According to published clinical literature, mastitis incidence in lactating women, with or without a breast pump, can be as high as 33%.In fact, clinical guidelines recommend the use of a breast pump to facilitate the removal of breast milk during periods of mastitis.Additionally, complaint trends across all medela pumps show mastitis incidence consistently below 0.1%, far lower than the 3-20% occurrence in the general population of lactating women "[2]".

• Brand Name: Freestyle Hands-free EN ES FR
• Common Device Name: Pump, Breast, Powered
• Manufacturer (Section D): Medela AG; 4b lattichstrasse; baar zug 6340 ; SZ 6340
• Manufacturer (Section G): Medela AG; lattichstrasse 4b; baar zug 6340 ; SZ 6340
• Manufacturer Contact: alea raber ; 1101 corporate drive; mchenry, IL 60050 ; +1(800)435-8316
• MDR Report Key: 50714764
• Report Number: 1419937-2026-00028
• Device Sequence Number: 10598769
• 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
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 101044164
• Device Catalogue Number: 101044164
• Device Lot Number: 0000753138
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2026
• 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