MAUDE Adverse Event Report: MEDELA AG HANDS-FREE PUMP PT-A EN ES FR; PUMP, BREAST, POWERED

Model Number	101044164
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 7/19/2023, the customer alleged to medela llc that her freestyle hands free breast pump will not power on.On 7/19/2023, the customer also emailed that her freestyle hands free was failing her.Additionally, she alleged that it started with being unable to use the touch screen occasionally and having to reset it but tonight the vacuum decreased on its own and then shut, off despite having two bars of charge.She alleged that she could turn it back on to start a new pump cycle, but it turned off again within 2 minutes.She also alleged that she has tried leaving it plugged into the wall and it is not resolving the issue.The customer also alleged that she had mastitis twice.
Additional Manufacturer Narrative
On (b)(6) 2023, the customer called in to customer service and they conducted troubleshooting with the customer, including inspecting power supply for damage, resetting the battery, verified no milk backup occurred and verified user was not washing or drying tubing on pump.The troubleshooting did not resolve the issue.The customer was sent a replacement swing pump, to use as the freestyle hands free was unavailable at the time and will be sent at a later date.The return of her original pump was requested for testing/evaluation.On (b)(6) 2023, the customer was sent a freestyle hands free pump.In follow up with a complaint handler on 7/30/2023, the customer stated that she developed mastitis on (b)(6) 2023 and again on (b)(6) 2023, both times she received a prescription antibiotic from her doctor.Additionally, she stated that the mastitis is resolved.The customer also stated that the replacement pump is working well but is less freeing and cannot be as independent.Based on the results of our internal investigation (reference number ca11-001), 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 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: HANDS-FREE PUMP PT-A EN ES FR
• 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: 17469637
• Report Number: 3002807523-2023-00013
• Device Sequence Number: 14912336
• Product Code: HGX
• UDI-Device Identifier: 00020451441641
• UDI-Public: 020451441641
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/07/2023

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: 0000337553
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2023
• Initial Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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