MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number	101036449
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer; including inspecting the faceplate and back plate for damage, and inspecting and cleaning the diaphragm.Following troubleshooting, the customer indicated that the suction was restored.In follow up with a complaint handler on 01/25/2020, the customer indicated that while exclusively pumping with her pump in style breast pump, she developed mastitis three times and was diagnosed on (b)(6) 2020.She additionally indicated she had been prescribed antibiotics and her mastitis was resolved, but she struggles with low supply and would like additional information on replacing the pump since it is her only pump.The complaint handler recommended that she contact customer service for a replacement if she was still having issues with her pump.The customer was subsequently contacted by a complaint handler in writing, requesting that she contact customer service.As of the date of this report, the customer has not contacted customer service nor replied to the complaint handler.Based on the results of (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 or mastitis." riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On (b)(6) 2020, the customer alleged to medela llc that her pump in style breast pump had been making a clicking sound and had low suction.She additionally alleged that she had a clogged duct that developed into mastitis, but this occurred before she started having issues with her breast pump.

• Brand Name: PUMP IN STYLE ADVANCED ON-THE-GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry, il
• MDR Report Key: 9717299
• Report Number: 1419937-2020-00011
• Device Sequence Number: 3650525
• Product Code: HGX
• UDI-Device Identifier: 00020451364490
• UDI-Public: 020451364490
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 101036449
• Device Catalogue Number: 101036449
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2020
• Initial Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other