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

Model Number	101041265
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the customer alleged to medela llc that it was taking her a long time empty herself due to the suction on her pump in style max flow and is engorged.Additionally, she alleged that she went to (b)(6) over the weekend due to mastitis and was placed on an antibiotic.
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer confirming no milk backup had occurred; and verifying correct kit components were being used and washed according to our instructions for use.The troubleshooting did not resolve the issue.A replacement device was sent to the customer and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 5/4/2022, the customer stated that her mastitis started around (b)(6) 2022 and she was prescribed keflex by her doctor.The customer also indicated that she has completed her antibiotic and the replacement pump is working well.The device was returned without the customer's parts and accessories; therefore, it was evaluated on 5/09/2022, with a medela lab kit and did not pass suction and cycle specifications.The evaluation found human milk residue in the pump aggregate (motor and pump assembly).The customer's report of low suction was confirmed.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 (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: PUMP IN STYLE WARRANTY 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 drive; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 14345621
• Report Number: 1419937-2022-00044
• Device Sequence Number: 11798242
• Product Code: HGX
• UDI-Device Identifier: 00020451412658
• UDI-Public: 020451412658
• 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
• Report Date (Section B): 05/10/2022

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: 101041265
• Device Catalogue Number: 101041265
• Device Lot Number: 0000039999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Distributor Facility Aware Date: 04/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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