MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number	101036453
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2020
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; disassembling, inspecting, cleaning and reassembling the kit and tubing set; and verifying breast shield fit.Customer service also asked the customer to place the end of the tubing on her arm to test the suction and she indicated that the pump had no suction.Customer service requested proof of purchase.On (b)(6) 2020, the customer emailed pictures to customer service via email and indicated that she suspected the issue was with the motor, to which customer service responded with additional troubleshooting on (b)(6) 2020.On (b)(6) 2020, the customer emailed her proof of purchase and indicated that she conducted the additional troubleshooting, which did not resolve the suction issue.She additionally alleged that she had mastitis in one breast.Replacement parts and accessories were sent to the customer.In follow up with a complaint handler on (b)(6) 2020, the customer indicated she was prescribed an antibiotic which she just finished and was feeling better.The customer also indicated that she had mastitis three times since january.Additionally the customer indicated that the replacement parts did resolve the suction issue, so the customer was referred to contact customer service.On (b)(6) 2020, the customer contacted customer service and a replacement pump was sent to the customer.In follow up by the complaint handler again on (b)(6) 2020, the customer indicated that the replacement pump was working without issue.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 (b)(6) that she was experiencing low suction with her pump in style breast pump.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 10105841
• Report Number: 1419937-2020-00053
• Device Sequence Number: 908242
• Product Code: HGX
• UDI-Device Identifier: 00020451364537
• UDI-Public: 020451364537
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 101036453
• Device Catalogue Number: 101036453
• Device Lot Number: 455276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 06/01/2020
• 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