MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN); PUMP, BREAST, POWERED

Model Number	101041360
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including verifying the customer is using the correct pump accessories; verifying customer is washing and drying accessories according to the pump's ifu and verifying customer did not have milk backup.The customer said she feels there is air coming from the tubing port and the pump sounds fine.The customer was using a sterilizer on the pump accessories, and we advised her against that since it can warp our parts and cause the issue of low suction.Customer service sent the customer new pump accessories.In follow up with a complaint handler on (b)(6) 2025, the customer indicated that she went to the doctor for strong pain on (b)(6) 2025 and was diagnosed with mastitis.She indicated that the replacement pump was working without issue and her mastitis was resolved.Based on the results of our internal investigation (reference number ca11-001), it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is (b)(4) for the period of january 2013 to august 2017.Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However, in this case, the mother¿s mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On (b)(6) 2025, the customer alleged to medela llc that her pump in style maxflow breast pump was having low suction.Additionally, the customer alleged she had developed mastitis from not being able to pump her breast milk.She went to the doctor and was prescribed antibiotics to treat the mastitis.

• Brand Name: PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)
• 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: 21677473
• Report Number: 1419937-2025-00001
• Device Sequence Number: 8311473
• Product Code: HGX
• UDI-Device Identifier: 00020451401447
• UDI-Public: 00020451401447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/24/2025

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: 101041360
• Device Catalogue Number: 101041360
• Device Lot Number: 0000719973
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/24/2025
• Date Device Manufactured: 12/06/2024
• 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