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	05/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent a replacement pump and membranes and return of her original pump and membranes was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2025, the customer indicated that she developed mastitis on (b)(6) 2025 and was prescribed cephalexin, which she's just about finished with.She indicated that the replacement pump was working without issue and her mastitis was resolved.The device was evaluated on 05/28/2025, it was found that the pump had low suction with the medela lab kit and customer's kit.Residue was found in the aggregate.After cleaning aggregate vacuum readings are in spec.Based on the results of our internal investigation (reference number (b)(4)), 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 (b)(4) for the period of (b)(6) 2013 to (b)(6) 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.
Event or Problem Description
On (b)(6) 2025, the customer alleged to medela llc that her pump in style handsfree pump was creating suction on only one side.Customer service conducted troubleshooting with the customer including verifying no milk back up had occurred, no damage to the power cord and dc jack.The customer stated she had been using an electric sterilizer which we do not recommend since that can damage/warp our parts.Customer service asked the customer for a proof of purchase to replace parts and she said she will call back with that.On (b)(6) 2024, the customer called back into medela with her proof of purchase to get her replacement pump parts.The customer stated she had developed mastitis due to not being able to pump and received antibiotics from her medical provider.

• 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: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 22094634
• Report Number: 1419937-2025-00012
• Device Sequence Number: 12489367
• Product Code: HGX
• UDI-Device Identifier: 00020451454368
• UDI-Public: 00020451454368
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/28/2025

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: 0000714749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Distributor Facility Aware Date: 05/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2024
• 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