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

Model Number	101046709
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the customer alleged to medela llc that she was in excruciating pain, and it feels as if her nipple is being pinched, she believes she has the wrong breast shield size.She reported she has mastitis and believes it's from using her swing maxi breast pump.Her doctor prescribed her antibiotics.
Additional Manufacturer Narrative
Customer service sent a replacement breast pump and requested the return of her breast pump and parts.In follow up with a complaint handler on (b)(6) 2026, the customer reported she has finished her antibiotics, her milk supply is still decreased.She is using the new breast shields, and they are working much better.The customer's pump was tested on (b)(6) 2026 and no problem was found.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: 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 drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 24199673
• Report Number: 1419937-2026-00004
• Device Sequence Number: 5507924
• Product Code: HGX
• UDI-Device Identifier: 00020451467092
• UDI-Public: 00020451467092
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/28/2026

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: 0000733226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Distributor Facility Aware Date: 01/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2025
• 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