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	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the customer alleged to medela llc that her pump in style max flow has low suction and she has mastitis.
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including disassembling, inspecting, cleaning; verifying no milk backup occurred and verifying the correct size breast shields were being used.During troubleshooting it was indicated by the customer that her nipples were rubbing against the side of the tunnel while using the 24mm breast shields so 27mm breast shields and a replacement pump were sent to the customer.The return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 5/25/2022, the customer stated that she started having symptoms of mastitis on (b)(6) 2022 but was not diagnosed until (b)(6) 2022 and was prescribed an antibiotic.Additionally, she indicated that the replacement pump is working well but has not tried the new parts yet.The device was evaluated on 06/07/2022, with the customer's parts and the medela lab kit and the suction tested low.It was noted in the evaluation that there was human milk residue in the tubing and motor 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: 14644704
• Report Number: 1419937-2022-00056
• Device Sequence Number: 14682229
• Product Code: HGX
• UDI-Device Identifier: 00020451412658
• UDI-Public: 020451412658
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/09/2022

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: 0000042911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Distributor Facility Aware Date: 05/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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