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	08/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the customer alleged to medela llc that she had a crack in her tubing to her pump in style hands free breast pump.She additionally reported that she currently has mastitis and is being treated with antibiotics.
Additional Manufacturer Narrative
Customer service sent the customer a new pump and parts and request of her old pump and parts be sent back to medela for testing/analyzing.In follow up with a complaint handler on 08/19/2025, the customer stated she is using a hospital grade medela pump, and her mastitis is resolved.Based on the results of our internal investigation (reference number ca11-001), it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is 0.008% for the period of january 2013 to august 2017.Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However, in this case, the mother¿s mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.

• 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: 22862391
• Report Number: 1419937-2025-00021
• Device Sequence Number: 9230976
• Product Code: HGX
• UDI-Device Identifier: 00020451454368
• UDI-Public: 00020451454368
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/21/2025

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/21/2025
• 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