MAUDE Adverse Event Report: MEDELA LLC Pump In Style Hands-free Retail EN ES; Pump, Breast, Powered

Model Number	101045436
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the customer alleged to medela llc that she had no suction with her pump in style hf breast pump.The customer also alleged that she developed mastitis and got medication.
Additional Manufacturer Narrative
Customer service sent a replacement pump to the customer and requested the old pump back for evaluation and testing.Multiple attempts to follow up with the customer by a complaint handler have gone unanswered 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]".

• Brand Name: Pump In Style Hands-free Retail 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 raber ; 1101 corporate drive; mchenry, IL 60050 ; +1(800)435-8316
• MDR Report Key: 50082194
• Report Number: 1419937-2026-00020
• Device Sequence Number: 10760818
• Product Code: HGX
• UDI-Device Identifier: 00020451454368
• UDI-Public: 00020451454368
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 101045436
• Device Catalogue Number: 101045436
• Device Lot Number: 0000743828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 11/12/2025
• 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