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	Power Problem (3010)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the customer alleged to medela llc that her pump in style breast pump would turn off while using it.Additionally, the customer alleged that she developed clogged ducts and mastitis.
Additional Manufacturer Narrative
Customer service sent a replacement pump to the customer and requested the original pump back for evaluation.On 04/02/2026, in follow up with a complaint handler the customer stated that she developed mastitis in mid-march and was prescribed kelflex, which is resolved.Additionally, the customer stated that the replacement pump is absolutely amazing and is fully emptying her breast.The evaluation of the customers pump determined that the customers pump does not power on with lab or customers transformer.The customers transformer powers on lab pump.The evaluation found that there was a damaged component on pc board.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: 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 drive; mchenry IL 60050
• Manufacturer Contact: alea raber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 24814578
• Report Number: 1419937-2026-00010
• Device Sequence Number: 9686926
• Product Code: HGX
• UDI-Device Identifier: 00020451401447
• UDI-Public: 00020451401447
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/08/2026

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: 101041360
• Device Catalogue Number: 101041360
• Device Lot Number: 0000726244
• Distributor Facility Aware Date: 04/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2025
• 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