MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE AMAZON EN FR ES (YELLOWFIN); PUMP, BREAST, POWERED

Model Number	101041362
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the customer alleged to medela llc while using her pump in style maxflow pump it was having issues staying powered on.The customer also alleged she had mastitis previously and was prescribed antibiotics.
Additional Manufacturer Narrative
Customer service asked the customer to try and use the battery pack with her pump to see if it will power on.The customer was asked to call back once she was able to test the battery pack, as of the date of this report the customer has not done so.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.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.
Additional Manufacturer Narrative
In follow up with a complaint handler on 03/22/203, the customer indicated that she developed mastitis approximately a few months prior to reaching out to medela in march and was prescribed an antibiotic.She indicated that the replacement pump was working without issue and her mastitis was resolved.

• Brand Name: PUMP IN STYLE AMAZON EN FR ES (YELLOWFIN)
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 16574409
• Report Number: 1419937-2023-00013
• Device Sequence Number: 6117303
• Product Code: HGX
• UDI-Device Identifier: 00020451401461
• UDI-Public: 020451401461
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200508
• 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
• Report Date (Section B): 03/27/2023

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: 101041362
• Device Catalogue Number: 101041362
• Device Lot Number: 0000037236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/09/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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