MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE PRO TRADITIONAL EN ES; PUMP, BREAST, POWERED

Model Number	01047090
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2026, the customer stated that she developed mastitis on (b)(6) 2025 and was prescribed antibiotics for two weeks.Additionally, she indicated that the mastitis is resolved and she is using the replacement pump.The pump was evaluated on 1/13/2026, and no problem was found when testing with the customer¿s kit.Mastitis is a common condition affecting many lactating women, with 1675 mastitis complaints between 01/2016 - 12/2024 across symphony, harmony, freestyle, freestyle flex, sonata, pns, pnsfx, pnshf, swing and swing maxi.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.
Event or Problem Description
On (b)(6) 2025, the customer alleged to medela llc that her pump in style pro was making a thumping noise, and the suction was not consistent.Additionally, she alleged that she developed several episodes of mastitis and was prescribed antibiotics.

• Brand Name: PUMP IN STYLE PRO TRADITIONAL EN ES
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 24065753
• Report Number: 1419937-2026-00001
• Device Sequence Number: 9388064
• Product Code: HGX
• UDI-Device Identifier: 00020451470900
• UDI-Public: 00020451470900
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K200508
• 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): 01/14/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 01047090
• Device Lot Number: 0000736368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Distributor Facility Aware Date: 12/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2025
• 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