MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number	57081
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A replacement pump was sent to the customer.The product involved in the complaint was not returned for evaluation/investigation at this time.  therefore, no conclusions can be made as to the cause of the event.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
The customer reported to customer service on (b)(6) 2017, that she had low suction on her pump in style breast pump.The customer also stated that has mastitis and was prescribed clindamycin by her doctor.
Additional Manufacturer Narrative
The customer was contacted by a medela clinician on (b)(6) 2017, at which time she reported that her replacement pump was working without issue.The customer also reported that her mastitis was resolved.The customer stated that she was taking lecithin and her plugged ducts resolved.The medela clinician informed her that if repeated plugged ducts occur despite taking lecithin, that another option to empty more efficiently is the use of a symphony pump.The medela clinician also referred her to the website for (b)(6) information and rental locations.The attached product evaluation determined that the returned pump operated to specification and passed all functional tests, including minimum and maximum vacuum and cycle tests for single and double pumping in both stimulation and expression modes when using the customer's kit.It was noted in the product evaluation that the valves that were returned with the pump were non-medela product.

• Brand Name: BREASTPUMP PNSA STARTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 6523579
• Report Number: 1419937-2017-00126
• Device Sequence Number: 734505
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 0100020451570815
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 05/24/2017

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: 57081
• Device Catalogue Number: 57081
• Device Lot Number: 433260
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/25/2017
• 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