MAUDE Adverse Event Report: MEDELA LLC SWINGMAXI HANDSFREE PUMP EN ES FR; PUMP, BREAST, POWERED

Model Number	101046709
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the customer alleged to medela llc that her swing maxi breast pump was not producing suction and wasn't automatically turning off.She additionally reported that she had mastitis while using the pump and was treated with antibiotics.
Additional Manufacturer Narrative
The customer was sent a new breast pump and requested to return the old breast pump for testing/analyzing.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.The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on (b)(6) 2025 and it had low suction when tested with a lab kit.There was residue found on the aggregate.Mastitis is a common condition affecting many lactating women, with 1675 mastitis complaints between (b)(6) 2016 - (b)(6) 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 can-not 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: SWINGMAXI HANDSFREE PUMP EN ES FR
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: tom cuzman ; 1101 corporate dr; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 23875912
• Report Number: 1419937-2025-00033
• Device Sequence Number: 15865697
• Product Code: HGX
• UDI-Device Identifier: 00020451467092
• UDI-Public: 00020451467092
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210759
• 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): 12/23/2025

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: 101046709
• Device Catalogue Number: 101046709
• Device Lot Number: 0000739898
• Distributor Facility Aware Date: 12/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2025
• 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