MAUDE Adverse Event Report: MEDELA AG FREESTYLE BREAST PUMP - SINGLE; PUMP, BREAST, POWERED

Model Number	101034712
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, customer service sent the customer troubleshooting tips in a response email, requesting that the customer contact them if the tips did not resolve the suction issue.On (b)(6) 2019, the customer called customer service and troubleshooting with the customer was conducted, including disassembling, inspecting, cleaning and reassembling the kit and tubing set.The customer was sent replacement parts and accessories to try.On (b)(6) 2019, the customer called back after receiving the replacements parts and indicated that the suction issue was not resolved.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 (b)(6) 2018, the customer indicated that around the beginning of 2019, she noticed that she started to frequently get areas on her breasts that were appearing to not be fully drained, as the tissue was not soft and had hard tender areas.The customer alleged that she developed mastitis in (b)(6) 2018, for which she was prescribed an antibiotic.Since then, she indicated that she was diligent about staying on a pumping schedule and addressing the clogged ducts with moist heat and manual massage.The customer also indicated that the pump still worked, but the suction appeared to be very low.In follow up with a complaint handler on 03/01/2019, the customer indicated that the replacement pump was working without issue and the mastitis was resolved.Based on the results of (b)(6), 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 via email that she purchased a freestyle breast pump (partly covered by insurance) back in (b)(6) and had been using the pump multiple times daily since (b)(6) and feels that the vacuum suction has lost a lot of power recently.She further alleged that she was not expressing nearly as much as she does when using an alternate new pump in style breast pump and was experiencing a lot of blocked ducts when using the freestyle pump.
Additional Manufacturer Narrative
The device was returned with the customer's parts and accessories and was evaluated on (b)(6)2018 and it did not meet vacuum specifications.The pump was retested using a medela kit and also did not meet vacuum specifications.Refer to the attached product evaluation report.It was identified in the evaluation that the membrane plate on the motor aggregate was damaged (refer to attached picture), which confirms the customer's report of low suction; however, ca11-001 found that it cannot be definitively concluded that a low vacuum breast pump causes or contributes to mastitis.

• Brand Name: FREESTYLE BREAST PUMP - SINGLE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• MDR Report Key: 8416660
• Report Number: 1419937-2019-00034
• Device Sequence Number: 11141860
• Product Code: HGX
• UDI-Device Identifier: 00020451670607
• UDI-Public: 00020451670607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup

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: 101034712
• Device Catalogue Number: 101034712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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