MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS-FREE BREASTPUMP; PUMP, BREAST, POWERED

Model Number	67060
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/14/2019
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.The troubleshooting did not resolve the issue.The customer refused to return the pump and parts for testing/analyzing.In follow up with a complaint handler on (b)(6) 2019, the customer confirmed that she developed mastitis and was prescribed an antibiotic.She indicated that her mastitis was resolved.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, is 0.008% 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 that her freestyle breast pump stopped suctioning after five minutes and she was worried about getting a 3rd bout of mastitis.

• Brand Name: FREESTYLE HANDS-FREE BREASTPUMP
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• MDR Report Key: 8790178
• Report Number: 1419937-2019-00094
• Device Sequence Number: 16644107
• Product Code: HGX
• UDI-Device Identifier: 00020451670607
• UDI-Public: 00020451670607
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150499
• 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: 67060
• Device Catalogue Number: 67060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/15/2019
• 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