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	07/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Troubleshooting was performed with the customer, including disassembling, inspecting, cleaning and reassembling components/accessories and verifying breast shield fit.After troubleshooting, the customer indicated that the suction had not improved.A replacement breast pump was sent to the customer and the original pump was requested for return.On 08/09/2017, a follow up was done with the customer and she stated that she was diagnosed with mastitis and treated with an antibiotic.She also stated that her mastitis has since resolved and her replacement pump was working fine.Based on the results of ca11-001, 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 and 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 that her pump in style advanced breast pump had low suction and she was engorged.She also stated that she had mastitis right after she had her baby.

• Brand Name: BREASTPUMP PNSA STARTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; mchenry IL
• MDR Report Key: 6826466
• Report Number: 1419937-2017-00240
• Device Sequence Number: 13582832
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 00020451570815
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 08/28/2017

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: 434664
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 08/29/2017
• 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