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	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer by disassembling, inspecting, cleaned and/or reassembled kit and tubing set.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 to get additional information, with no response as of the date of this report except that her family has covid and will not be returning the pump at this time.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) 2022, the customer alleged to medela llc that her pump in style max flow has low suction and she developed mastitis for which she was prescribed an antibiotic.
Additional Manufacturer Narrative
On 2/18/2022, in follow up with a complaint handler the customer indicated that the mastitis started on (b)(6) 2022, which has cleared up now after taking the iv antibiotics.Additionally, she indicated that she has not tried the replacement pump and that she is using a hospital pump.The device was returned with the customer's parts and accessories and was evaluated on 03/16/2022.The device passed suction and cycle specifications.It was also noted in the evaluation that there was milk residue on the connectors and membranes.The customer's report of low suction could not be confirmed.

• 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: 13514818
• Report Number: 1419937-2022-00015
• Device Sequence Number: 4207160
• Product Code: HGX
• UDI-Device Identifier: 00020451412658
• UDI-Public: 020451412658
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/17/2022

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: 0000037230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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