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	Abscess (1690)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer stopped responding to customer service during the chat.The customer was contacted by a complaint handler on multiple occasions, to get additional information, with no response as of the date of this report.
Event or Problem Description
On (b)(6) 2025, the customer alleged to medela llc while using her pump in style hands-free breast pump, her pump stopped suctioning.The customer also alleged she developed an abscessed infection.

• 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 dr; mchenry IL 60050
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 23862625
• Report Number: 1419937-2025-00032
• Device Sequence Number: 9299580
• Product Code: HGX
• UDI-Device Identifier: 00020451454368
• UDI-Public: 00020451454368
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/22/2025

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: 101045436
• Device Catalogue Number: 101045436
• Device Lot Number: 0000727484
• Distributor Facility Aware Date: 11/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 03/25/2025
• 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