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

Model Number	57063
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Swelling (2091)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Troubleshooting was conducted with the customer, including inspecting the face and back plates for damage and inspecting and/or cleaning the diaphragm.A failure could not be identified as a result of the troubleshooting.The customer was sent a replacement breast pump.The customer's pump was received without parts and accessories.The pump was tested with a lab kit and passed all testing.The evaluation found that there was residue on the diaphragm.Based on the results of (b)(4), it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis."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) 2017, the customer alleged to medela llc that she was experiencing low suction with her pump in style advanced breast pump.She reported that she had been to the doctor four times and was diagnosed with mastitis twice, for which she was prescribed antibiotics.The customer also mentioned that she gets clogged ducts twice a week.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 6887888
• Report Number: 1419937-2017-00267
• Device Sequence Number: 496503
• Product Code: HGX
• UDI-Device Identifier: 00020451570631
• UDI-Public: (01)00020451570631
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 09/22/2017

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: 57063
• Device Catalogue Number: 57063
• Device Lot Number: 436007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Distributor Facility Aware Date: 08/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/22/2017
• 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