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

Model Number	101043614
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the customer alleged to medela llc that she has flat nipples and her swing maxi breast pump was not working for her.She additionally alleged she had developed mastitis from not being able to use her pump.
Additional Manufacturer Narrative
Customer service conducted troubleshooting including; verifying the user was not washing or drying tubing on the pump; verifying the parts were dry when pumping; verifying user was washing parts according to the instruction for use; and verifying user was using correct kit components.Return of the original pump was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2022, the customer's husband indicated that she developed mastitis on (b)(6) 2022 and was prescribed an antibiotic.He stated his wife's mastitis is resolved after finishing a course of antibiotics.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.

• Brand Name: SWING MAXI
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 14348446
• Report Number: 1419937-2022-00045
• Device Sequence Number: 14491961
• Product Code: HGX
• UDI-Device Identifier: 00020451436142
• UDI-Public: 020451436142
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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: 0000038104
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/10/2022
• Date Device Manufactured: 11/22/2021
• 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