MAUDE Adverse Event Report: MEDELA LLC SWING MAXI MILCHPUMPE EN ES FR MEDICAL D; PUMP, BREAST, POWERED

Model Number	101043614
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer has been requested to contact customer service so that her issue can appropriately be addressed.As of the date of this report, the customer has not done so.In follow up with a complaint handler on 11/29/23, the customer indicated that she developed mastitis on 11/09/23 and was prescribed three different antibiotics, which she is almost completed with.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.(b)(4).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 11/25/23, the customer emailed into medela llc stating she had issues with swing maxi pump.The customer also alleged she developed mastitis twice due to not being able to breast pump effectively.

• Brand Name: SWING MAXI MILCHPUMPE EN ES FR MEDICAL D
• 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; mcherny IL 60050
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 18266024
• Report Number: 1419937-2023-00039
• Device Sequence Number: 4006880
• Product Code: HGX
• UDI-Device Identifier: 00020451436142
• UDI-Public: 020451436142
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/05/2023

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: 101043614
• Device Catalogue Number: 101043614
• Device Lot Number: 0000588956
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/25/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/05/2023
• Date Device Manufactured: 01/09/2023
• 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