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

Model Number	101041360
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the customer alleged that she had low suction on her pump in style max flow breast pump.Additionally, the customer alleged that she developed mastitis twice due to the pump not suctioning.
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including disassembling, inspecting, cleaning and reassembling the kit and tubing set; confirming no milk backup had occurred; verifying correct kit components were being used and washed according to our instructions for use and verifying breast shield fit.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 2/27/2023, the customer indicated that she developed mastitis twice.The first time was on (b)(6) 2023 and then again on (b)(6) 2023.Additionally, she indicated that she was prescribed an antibiotic and the mastitis is now resolved.The customer indicated that the replacement pump has much better suction then the previous pump but still does not release all her supply completely.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 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.
Additional Manufacturer Narrative
The device was returned with the customer's parts and accessories and was evaluated on 03/07/2023.The device passed suction and cycle specifications.The customer's report of low suction could not be confirmed.

• 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: 16484709
• Report Number: 1419937-2023-00012
• Device Sequence Number: 20562749
• Product Code: HGX
• UDI-Device Identifier: 00020451401447
• UDI-Public: 020451401447
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/07/2023

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: 0000289454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/21/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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