MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE PRO TRADITIONAL EN ES; PUMP, BREAST, POWERED

Model Number	101047090
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service sent the customer a replacement pump and request of her pump to be returned to medela.The customer responded to a complaint handler on 1/12/2026, she stated her mastitis began around (b)(6) 2026 when she was admitted to the hospital.She is getting better suction and milk output with her replacement breast pump.Her mastitis has improved with using the new pump.She stated she will be returning her old pump but has not used the return label sent to her as of the date of this report.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 01/07/2026, the customer alleged to medela llc that from the beginning she experienced low suction with her pump in style pro breast pump.She additionally alleged that she developed mastitis, was admitted to the hospital and prescribed antibiotics.
Additional Manufacturer Narrative
The customer's pump was evaluated on 01/27/2026, it was found to have damage to the tubing and residue in the aggregate.

• Brand Name: PUMP IN STYLE PRO TRADITIONAL EN ES
• 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
• MDR Report Key: 24129030
• Report Number: 1419937-2026-00003
• Device Sequence Number: 14804357
• Product Code: HGX
• UDI-Device Identifier: 00020451470900
• UDI-Public: 00020451470900
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• 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: 101047090
• Device Catalogue Number: 101047090
• Device Lot Number: 0000739339
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/07/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2025
• 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