MAUDE Adverse Event Report: MEDELA LLC SONATA DELUXE SINGLE PACK; PUMP, BREAST, POWERED

Model Number	58200
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Troubleshooting was performed with the customer, including inspecting components/accessories for damage and cleaning/reassembling component/accessories.Troubleshooting indicated that the device produced suction, but it needed to be turned to level 10.The customer indicated that she has multiple components/accessories and replacing them did not resolve the suction issue.An unusual noise was not noted during troubleshooting and an air leak message was not displayed.Based upon the troubleshooting results, a replacement device was sent to the customer.It cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.Reported issues of mastitis are under investigation in (b)(4).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 customer service that her sonata breast pump was louder "than it was before" and she had to turn it up to a level 10 for suction.She was diagnosed last week with mastitis which was treated with penicillin, but she is fine now.

• Brand Name: SONATA DELUXE SINGLE PACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 6573474
• Report Number: 1419937-2017-00143
• Device Sequence Number: 1169934
• Product Code: HGX
• UDI-Device Identifier: 00020451582009
• UDI-Public: (01)00020451582009
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K161725
• 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): 05/17/2017

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: 58200
• Device Catalogue Number: 58200
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/17/2017
• 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