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

Model Number	101044164
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 24 the customer emailed medela llc that her freestyle handsfree pump stopped holding a charge.Additionally, the customer reported she had developed mastitis.
Additional Manufacturer Narrative
The customer has been requested to contact customer service so that her issue can appropriately be addressed.As of the date of this report, the customer has not done so.In follow up with a complaint handler on 04/16/24, the customer indicated that she is prone to developing mastitis if she does not pump regularly.The customer stated that her mastitis is a result of not having a pump to use, not directly because of her freestyle handsfree pump.The customer stated she developed mastitis on (b)(6) 24 and was prescribed an antibiotic.The customer also stated she had not contacted customer service yet because she already purchased a different brand pump, and she was not prioritizing calling to troubleshoot.Her mastitis is 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).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: 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: 19132283
• Report Number: 3002807523-2024-00006
• Device Sequence Number: 6891326
• 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): 04/18/2024

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: 0000610196
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/02/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/18/2024
• Date Device Manufactured: 08/23/2023
• 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