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

Model Number	57081
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A replacement pump was sent to the customer.Attempts to contact the customer for further information and the device return have been unsuccessful.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.It cannot be definitively concluded that the pump caused or contributed to the customer¿s thrush.Reported issues of thrush are under investigation in (b)(4).
Event or Problem Description
On (b)(6) 2017, the customer reported to a medela customer service representative that the let down button was not working properly on her pump in style breast pump.At that time she also reported that on (b)(6) 2017, she was seen by her physician and had been prescribed doxycillin and was seen again on (b)(6) 2017, and prescribed kflex for a yeast infection.
Additional Manufacturer Narrative
The pump was evaluated on 4/3/2017.The kit components were found to be dirty.

• 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: 6411650
• Report Number: 1419937-2017-00076
• Device Sequence Number: 48183
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 0100020451570815
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/12/2017

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 04/12/2017
• 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