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

Model Number	101041361
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the customer alleged to medela llc while using her pump in style maxflow her pump stopped suctioning.Additionally the customer alleged she developed mastitis and was prescribed antibiotics.
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including verifying customer was using correct kit components, verifying customer was washing parts according to instruction for use manual, verifying customer was using dry parts while pumping and verifying customer was not washing tubing.When customer was asked if she had milk backup with her pump she indicated yes.A replacement pump, tubing and connectors were sent to the customer, and the return of her original pump was requested back for testing.In follow up with a complaint handler on (b)(6) 2022, the customer indicated that she developed mastitis three weeks after she began using her pump.She was prescribed an antibiotic, and she indicated that her mastitis was healed.The device was not returned to medela, only the customer's tubing was returned; therefore, it was evaluated with a medela lab pump on (b)(6) 2022.The tubing passed suction and cycle specifications while using the medela lab pump and kit.Also identified in the evaluation was human milk residue in the tubing.The customer's report of low suction could not be 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 (b)(6) 2013 to (b)(6) 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 RETAIL 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: 14999873
• Report Number: 1419937-2022-00058
• Device Sequence Number: 1614192
• Product Code: HGX
• UDI-Device Identifier: 00020451401454
• UDI-Public: 020451401454
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/13/2022

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: 101041361
• Device Catalogue Number: 101041361
• Device Lot Number: 0000038770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Distributor Facility Aware Date: 06/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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