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	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service replaced the customer's breast pump and requested her old pump be returned for testing/analyzing.On (b)(6) 2026, the customer responded to a complaint handler.She stated she had mastitis on (b)(6) 2026 and took antibiotics.Her new pump is working well so far.Her mastitis has been resolved.The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on 04/15/2026 and it passed suction and cycle specifications.The customer's report of low suction could not be confirmed.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].
Event or Problem Description
On (b)(6) 2026, the customer reached out to medela llc via instagram.She alleged that her swing maxi breast pump had low suction and the pump was shutting off after 5 min.She additionally reported that she had mastitis and was prescribed antibiotics by her healthcare provider.

• 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: alea raber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 24887944
• Report Number: 1419937-2026-00012
• Device Sequence Number: 9852050
• Product Code: HGX
• UDI-Device Identifier: 00020451467092
• UDI-Public: 00020451467092
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 04/15/2026

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: 101046709
• Device Catalogue Number: 101046709
• Device Lot Number: 0000746462
• Distributor Facility Aware Date: 03/23/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2025
• 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