MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE WARRANTY EN FR ES (YELLOWFIN); PUMP, BREAST, POWERED

Model Number	101041265
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/23/2021
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; verifying correct kit components were being used, washed, and dried according to our instructions for use; verifying correct breast shield fit and verifying no milk backup had occurred.The troubleshooting did not resolve the issue.A replacement pump was sent to the customer and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 10/06/2021, the customer indicated that she developed mastitis on (b)(6) 2021 and was prescribed an antibiotic.The customer also indicated that she is feeling better and her replacement pump is working without any issues.The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on 10/08/2021 and it passed suction and cycle specifications.The customer's report of low suction could not be confirmed.Based on the results of our internal investigation (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 (b)(4) 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 (b)(6) 2021, the customer alleged to medela llc that her pump in style max flow breast pump had low suction which led to mastitis.

• Brand Name: PUMP IN STYLE WARRANTY EN FR ES (YELLOWFIN)
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 12681478
• Report Number: 1419937-2021-00097
• Device Sequence Number: 14493408
• Product Code: HGX
• UDI-Device Identifier: 00020451412658
• UDI-Public: 020451412658
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200508
• 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: 101041265
• Device Catalogue Number: 101041265
• Device Lot Number: 0000028073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/22/2021
• 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