MAUDE Adverse Event Report: MEDELA LLC SONATA DELUXE SINGLE PACK; PUMP, BREAST, POWERED

Model Number	58200
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including disassembling, inspecting, cleaning and reassembling the kit and tubing set; and verifying breast shield fit.The troubleshooting did not resolve the issue.A replacement device was sent to the customer.In follow up with a complaint handler on 08/10/2020, the customer confirmed that she developed mastitis twice.She was able to clear the first bout with excessive pumping and was prescribed an antibiotic the second time on (b)(6) 2020.She was fitted for the correct breast shield size when her son was in the nicu.She uses her old pump in style and hand expression because her baby cannot latch.In additional follow up on 08/14/2020, the customer indicated that she finished the antibiotics and was fighting a clogged duct.Additionally, on (b)(6) 2020, she indicated that she still had to pick up the replacement pump from ups, but she would email once she had it to let us know how it was working for her.There has been further follow up by the complaint handler, including in writing, with no response from the customer as of the date of this report.Based on the results of 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 or mastitis." riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On 08/03/2020, the customer alleged to medela llc that she was experiencing low suction with her sonata breast pump.Additionally, she alleged that she developed mastitis twice due to the low suction and received antibiotics for the second bout.The customer indicated that she also has a pump in style breast pump that she was using and felt she was able to empty more milk with it than the sonata.

• Brand Name: SONATA DELUXE SINGLE PACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 10455886
• Report Number: 1419937-2020-00090
• Device Sequence Number: 16826052
• Product Code: HGX
• UDI-Device Identifier: 00020451582009
• UDI-Public: 00020451582009
• Combination Product (Y/N): N
• 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

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: 58200
• Device Catalogue Number: 58200
• Device Lot Number: 448991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other