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

Model Number 101041360

Device Problems Backflow (1064); Increase in Suction (1604)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 05/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 the customer emailed medela llc and alleged while she was pumping with her medela breast pump, milk started going into the tubing.She then contacted us back via phone and spoke with a customer service representative on (b)(6) 2022 and alleged that after the milk back up with her pump in style max flow suction wouldn't release and this was painful.She additionally alleged she had mastitis and was taking antibiotics.

Manufacturer Narrative

Customer service conducted troubleshooting including; verifying the user was using correct kit components; verifying the user was washing parts according to the instructions for use; verifying the user was using dry parts when pumping; verifying user was not washing or drying tubing on pump; and verifying there was no milk backup that occurred.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2022, the customer indicated that she developed mastitis when her pump broke.She has one more day of antibiotics, but her mastitis has cleared up.She indicated that the replacement pump was working properly.The device was returned with the customer's parts and accessories and was evaluated on 06/07/2022.The device was evaluated with a medela lab kit and the customer's parts.It was identified in the product evaluation the pump had high suction with the lab kit and the customer's kit.Human milk residue was found on the pump aggregate (pump motor and pump assembly), chassis, manifold and solenoid.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 MANAGED MARKETS EN FR ES (YELLOWFIN)
• Type of Device: 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: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 14642796
• MDR Text Key: 293635112
• Report Number: 1419937-2022-00055
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451401447
• UDI-Public: 020451401447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101041360
• Device Catalogue Number: 101041360
• Device Lot Number: 0000038768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Distributor Facility Aware Date: 05/26/2022
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female