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

Model Number	101041361
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the customer contacted medela llc customer service via email and alleged that her medela pump in style breast pump suddenly stopped working.Additionally, the customer alleged that she has mastitis.Customer service sent troubleshooting tips via email and advised the customer to call in if the issue was not resolved with the troubleshooting tips.On (b)(6) 2023, the customer called medela llc to troubleshoot her pump.
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; verifying user was using dry parts when pumping; and verifying user was not washing or drying tubing on pump.In follow up with a complaint handler on (b)(6) 2023, the customer stated that the power worked on the pump but when connecting the tubing to the pump there was no suction.The customer stated that she changed her parts and tubing, but it still didn't work.The customer also stated that she used the parts on an older model pump in style breast pump and they worked well.Additionally, the customer stated that she developed mastitis on (b)(6) 2023, and was prescribed an antibiotic.The customer also indicated that the mastitis is resolved.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 (b)(4).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.

• Brand Name: PUMP IN STYLE W/BTL STANDS 1CT EN ES FR
• 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: 17719444
• Report Number: 1419937-2023-00032
• Device Sequence Number: 7148538
• Product Code: HGX
• UDI-Device Identifier: 00020451401454
• UDI-Public: 020451401454
• 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): 09/11/2023

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: 101041361
• Device Catalogue Number: 101041361
• Device Lot Number: 0000031725
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/11/2023
• Date Device Manufactured: 09/01/2021
• 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