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

Model Number 101041360

Device Problems Decrease in Suction (1146); Obstruction of Flow (2423)

Patient Problem Unspecified Infection (1930)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

The customer was emailed troubleshooting tips which included, inspecting the power cord for any damage; ensuring the vacuum is turned all the way up to max comfort level for the customer; verifying the customer is using the correct kit components; verifying the customer was using clean and dry parts when pumping; verifying the customer did not have milk backup; verifying customer was not using electric sterilizer; provided information on having the correct breast shield sizing for proper milk expression.In follow up with the complaint handler on 8/19/2022, the customer indicated that the troubleshooting tips she received via email did not help the issue.She stated she developed mastitis around (b)(6) 2022.She was prescribed an antibiotic and the mastitis is currently resolved.The customer has been requested to contact customer service so that her issue can appropriately be addressed.As of the date of this report, the customer has not done so.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.

Event Description

On 8/9/2022, the customer alleged to medela llc while using her pump in style with maxflow she was experiencing low suction.Customer alleged she developed clogged ducts and mastitis.

• Brand Name: PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MINC; 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: 15275040
• MDR Text Key: 298394149
• Report Number: 1419937-2022-00067
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451401447
• UDI-Public: 020451401447
• Combination Product (y/n): N
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101041360
• Device Lot Number: 0000040003
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/19/2022
• Date Manufacturer Received: 08/19/2022
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female