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

Model Number	57063
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2019
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.The troubleshooting did not resolve the issue.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 02/15/2019, the customer confirmed that she developed mastitis on (b)(6) 2019 and was prescribed an antibiotic.She indicated that the mastitis was resolved, but she was still filling full because her breasts were not emptying, and that the replacement pump was not working well for her either.The customer was encouraged to contact customer service to troubleshoot and she was put in touch with a medela lactation consultant, who provided pumping techniques to help empty her breasts.Based on the results of (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, (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) 2019, the customer alleged to medela llc via email that her pump in style breast pump was "broken" and no longer empties her breasts; even when on maximum vacuum setting, it will not suction hard enough to even "grab her skin." she further alleged that she was getting clogged ducts and her supply was decreasing because she cannot get the pump to function as it used to.She indicated that she has bought all new parts multiple times.On (b)(6) 2019, the customer phoned medela llc, confirming low suction with both the battery pack and the power adapter and further alleging that she developed mastitis while pumping and breastfeeding.Her doctor advised her that her breasts were not emptying and she should pump more often and this is when she developed clogged ducts.She was put on an antibiotic a month previously for 10 days.She is better, but not being able to empty her breasts is not helping.

• 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 60050
• MDR Report Key: 8357263
• Report Number: 1419937-2019-00026
• Device Sequence Number: 2285261
• Product Code: HGX
• UDI-Device Identifier: 00020451570631
• UDI-Public: 00020451570631
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 57063
• Device Catalogue Number: 57063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/21/2019
• 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