MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE W/OUT BAG 1CT EN ES; PUMP, BREAST, POWERED

Model Number	101041360
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including confirming no milk backup had occurred; verifying correct kit components were being used and washed according to our instructions for use.Also verifying user was not washing or drying tubing on pump.The troubleshooting did not resolve the issue.A replacement device was sent to the customer and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 5/15/2023, the customer indicated that she began having pain but had to wait for a doctor appointment, so she is not exactly sure when she developed mastitis.The customer stated that she has tried the replacement pump and it feels a bit better than the one she is returning to medela.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.
Event or Problem Description
On (b)(6) 2023, the customer alleged to medela llc that her pump in style max flow breast pump was not working for her and that she was able to express more with the symphony breast pump.Additionally, she alleged that she developed mastitis and is being treated with an antibiotic.
Additional Manufacturer Narrative
The device was evaluated on 05/30/2023, with the customer's parts and the medela lab kit and there was low suction.The evaluation found residue on connectors, membranes and the motor aggregate.After cleaning the motor aggregate, the vacuum readings were within specification.

• Brand Name: PUMP IN STYLE W/OUT BAG 1CT 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: 16955274
• Report Number: 1419937-2023-00021
• Device Sequence Number: 3339519
• Product Code: HGX
• UDI-Device Identifier: 00020451401447
• UDI-Public: 020451401447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/30/2023

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: 101041360
• Device Catalogue Number: 101041360
• Device Lot Number: 0000042791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/05/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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