MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number	101036449
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including inspecting the faceplate and back plate for damage; inspecting and cleaning the diaphragm; and disassembling, inspecting, cleaning and reassembling the kit and tubing set.The troubleshooting did not resolve the issue.The customer was sent a replacement device and return of her original device was requested for testing/evaluation.In follow up with a complaint handler on 01/05/2021, the customer alleged that her replacement pump was also not working well, but she was using her hospital grade pump and manual pump without issue.The complaint handler suggested she contact customer service in regard to her replacement pump.In further follow up with a complaint handler on 01/11/2021, the customer indicated she had been prescribed antibiotics for her mastitis and reiterated that she was having a bad experience with her replacement pump, but was referred to call in to customer service for assistance by the complaint handler.In subsequent contact on 01/12/2021, she confirmed her mastitis was resolved and that she would follow up with customer service.As of the date of this report, the customer has not done so.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 (b)(6) 2013 to (b)(6) 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 (b)(6) 2020 the customer alleged to medela llc that her pump in style breast pump had high suction, which led to her getting mastitis and being prescribed a hospital grade pump.

• Brand Name: PUMP IN STYLE ADVANCED ON-THE-GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 11287334
• Report Number: 1419937-2021-00008
• Device Sequence Number: 17018782
• Product Code: HGX
• UDI-Device Identifier: 00020451364490
• UDI-Public: 020451364490
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181937
• 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: 101036449
• Device Catalogue Number: 101036449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/05/2021
• 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