MAUDE Adverse Event Report: MEDELA LLC SONATA PUMP W/FLEX SINGLE 1CT EN FR ES; PUMP, BREAST, POWERED

Model Number	101037319
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent a replacement pump and parts, the return of her original pump and parts was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2023, the customer indicated that she developed mastitis on (b)(6) 2023 and was prescribed an dicloxacillin.She indicated that the replacement pump was working without issue and her mastitis was resolved.The device was returned with the customer's transformer and was evaluated on (b)(6)2023.The device was tested with a lab transformer and the customer's transformer and the issue of no power was reproduced.In the evaluation it was discovered that the power board harness was loose/detached from the main board.Once the power board harness was re attached the pump powered on successfully.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.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.
Event or Problem Description
On 2/13/23, the customer alleged to medela llc while using her sonata breast pump it would not power on, the display would not show that the power cord was plugged in.The customer stated the pump ws droppped before the issue began.The customer also alleged that she developed mastitis and was prescribed antibiotics to treat it.

• Brand Name: SONATA PUMP W/FLEX SINGLE 1CT EN FR 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 dr; mchenry IL 60050
• Manufacturer Contact: thomas cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 16477004
• Report Number: 1419937-2023-00011
• Device Sequence Number: 12624874
• Product Code: HGX
• UDI-Device Identifier: 00020451367507
• UDI-Public: 020451367507
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161725
• 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): 03/03/2023

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: 101037319
• Device Lot Number: 0000043916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Distributor Facility Aware Date: 02/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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