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

Model Number	101034712
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service verified breast shield fit with the customer and determined that the 24mm breast shields were the correct size.The customer was sent o-ring assemblies for her harmony manual pumps, a replacement freestyle pump, and return of her original freestyle pump was requested for testing/evaluation.In follow up with a complaint handler on 12/20/2018, the customer indicated that she had developed mastitis twice, first in (b)(6) and then again two to three weeks ago, but it had since resolved.She additionally indicated that she was using a symphony breast pump at work without issue, but that she has to be still vigilant and make sure to hand express or use a harmony manual pump after using the freestyle pump to fully empty her breasts.In further follow up with a complaint handler on 12/27/2018, the customer indicated that the replacement freestyle pump was not working well for her because it was not providing consistent suction when double pumping.The complaint handler recommended that she contact customer service.The customer was contacted subsequently by a complaint handler on multiple occasions, including in writing, to request that she contact customer service so that her issue with the replacement pump could appropriately be addressed; however, as of the date of this report, the customer has not done so.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 (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) 2018, the customer alleged to medela llc that her freestyle breast pump was not emptying her breasts and her two harmony manual pumps were missing o-rings.She additionally alleged that she developed mastitis twice, had clogged ducts, and had seen a doctor who prescribed oral and cream antibiotics.She also stated that a lactation consultant recommended that she use a hospital-grade symphony breast pump.
Additional Manufacturer Narrative
The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on (b)(6)2019 and it passed suction and cycle specifications.Refer to attached evaluation.The customer's report of low milk expression could not be confirmed or refuted.

• 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: 8231173
• Report Number: 1419937-2019-00005
• Device Sequence Number: 1887456
• Product Code: HGX
• UDI-Device Identifier: 00020451670607
• UDI-Public: 00020451670607
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 01/07/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 01/17/2019
• 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