MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS-FREE EN ES FR - US ADAPTER; PUMP, BREAST, POWERED

Model Number	101044164
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the customer emailed medela llc stating her freestyle handsfree pump was having an issue with low suction.The customer also alleged she was diagnosed with mastitis.
Additional Manufacturer Narrative
The customer was advised by email to contact medela to troubleshoot her pump.The customer phoned medela llc on(b)(6) 2023 to troubleshoot her pump.Customer service conducted troubleshooting with the customer including disassembling, inspecting, cleaning and or reassembling kit and tubing set; verified the customer had the correct breast shield fit.The customer stated she had tried additional freestyle flex parts on her pump and the pump still had issues with low suction.The customer was sent a swing maxi pump and parts.In follow up with a complaint handler on (b)(6) 2023, the customer stated she was diagnosed with mastitis on (b)(6) 2023 and was prescribed dicloxacillin.She stated her mastitis is currently resolved.Based on the results of our internal investigation (reference number (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.(b)(4)the risk of mastitis is higher among women who have breastfed previously, especially those with a history of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However, in this case, the mother¿s mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.

• Brand Name: FREESTYLE HANDS-FREE EN ES FR - US ADAPTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 17169386
• Report Number: 3002807523-2023-00008
• Device Sequence Number: 15220495
• Product Code: HGX
• UDI-Device Identifier: 00020451441641
• UDI-Public: 020451441641
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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: 101044164
• Device Catalogue Number: 101044164
• Device Lot Number: 0000448798
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/21/2023
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female