MAUDE Adverse Event Report: MEDELA LLC SWING MAXI; PUMP, BREAST, POWERED

Model Number	101043614
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the customer alleged via email to medela llc that she was having charging issues with her swing maxi breast pump.It was working very well but now has to charge it every 2 pumping sessions.She additionally alleged that her breast pump was not pulling as effectively as it was before.She has an increased supply and has developed mastiti.
Additional Manufacturer Narrative
The customer called customer service on (b)(6) 2022 and went over troubleshooting with the customer service rep including; verifying there was no milk backup; disassembling, inspection, cleaning and reassembling kit and tubing; verifying correct breast shield size.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2022, the customer indicated that she developed mastitis on (b)(6) 2021 and was prescribed an antibiotic.She stated her mastitis is clearing up and she is almost finished taking her antibiotic.She has not yet followed up with customer service.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 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: SWING MAXI
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, il ; 4358316
• MDR Report Key: 13451124
• Report Number: 1419937-2022-00005
• Device Sequence Number: 14419976
• Product Code: HGX
• UDI-Device Identifier: 00020451436142
• UDI-Public: 020451436142
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 101043614
• Device Catalogue Number: 101043614
• Device Lot Number: 0000033510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2021
• 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