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	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 3/2/26, the customer emailed medela llc that while using the pump in style pro she was diagnosed with mastitis due to poor or insufficient emptying of her breasts.Additionally, she alleged that she was admitted to the hospital and received iv antibiotics.
Additional Manufacturer Narrative
Customer service sent a replacement pump to the customer and asked for the return of her old pump for evaluation.In follow up with a complaint handler on 3/6/2026, the customer stated that she was sent a replacement pump.Additionally, she stated that her infection is resolved but she still has recurring clogs that are manageable.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].
Additional Manufacturer Narrative
The pump and customer kit were tested on 4/01/2026, and the evaluation showed high suction when tested with the customer's kit.The pump was then evaluated with the lab kit, and the vacuum readings were in specification.It was also determined in the evaluation that the vacuum readings were in specification when tested with lab tubing and customer's kit.

• 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 drive; mchenry IL 60050
• Manufacturer Contact: alea raeber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 24629178
• Report Number: 1419937-2026-00006
• Device Sequence Number: 8698064
• Product Code: HGX
• UDI-Device Identifier: 00020451470900
• UDI-Public: 00020451470900
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/01/2026

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: 0000732229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/02/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2025
• 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