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

Model Number	101036449
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During troubleshooting with customer service, the customer indicated that she had purchased all new parts, which did not resolve the low suction issue.She also indicated that she had seen a lactation consultant in october, who indicated that she was using the correct size breast shields.Customer service asked for a proof of purchase which was submitted by the customer on (b)(6) 2020 and a replacement device was sent to the customer.The original pump was requested for testing/evaluation.In follow up with the complaint handler on (b)(6) 2020, the customer indicated that the mastitis was resolved.At that time, she did not have the replacement pump because she hadn't submitted a proof of purchase.The customer was contacted by a complaint handler on multiple occasions, including in writing, to inquire how the replacement pump was working and to get the original pump back, with no response 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 (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 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 low suction causing blocked milk ducts.She additionally alleged that she had mastitis over three months ago, for which she was prescribed antibiotics.

• Brand Name: PUMP IN STYLE ADVANCED ON-THE-GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenery, il
• MDR Report Key: 10038922
• Report Number: 1419937-2020-00042
• Device Sequence Number: 3867475
• Product Code: HGX
• UDI-Device Identifier: 00020451364490
• UDI-Public: 020451364490
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031614
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/08/2020
• 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