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	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer requested management of customer service to call her to issue a refund for the product instead of a replacement device.In follow up with a complaint handler on (b)(6) 2024, the customer said since her collection cups had broken, she was having pain from not being able to express her breast milk.The customer also stated she had developed mastitis twice and was prescribed antibiotics to treat it.The customer stated her lactation consultant said the reason this happened was because she was using the incorrect breast shield size to express her milk.The customer is asking about her refund, i told her management is aware and will be in contact with her.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.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 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.
Event or Problem Description
On (b)(6) 2024, the customer alleged to medela llc that the collection cups for her freestyle handsfree pump were broken on the bottom.The customer also alleged the breast shield size she was using was not her size, therefore she was not getting appropriate suction.The customer stated her lactation consultant recommended that she purchase breast shield inserts to make the breast shields fit her, but the customer did not want to use the device anymore.The customer also alleged; the cups hurt her.

• 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: 19687996
• Report Number: 3002807523-2024-00011
• Device Sequence Number: 20865811
• 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): 07/08/2024

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: 0000640757
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/28/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/08/2024
• Date Device Manufactured: 12/04/2023
• 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