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

Model Number	57081
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A replacement pump was sent to the customer.   the customer spoke with a medela clinician on 1/9/2017, at which time she reported that she did not develop mastitis due to the engorgement that she had initially reported and that her issues is resolved, but she had experienced mastitis previously.  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) 2016 the customer reported to a medela customer service representative that she was experiencing low suction with her pump in style breast pump and that she had been experiencing engorgement, fevers, and that she had been prescribed antibiotics.

• 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: 6271067
• Report Number: 1419937-2017-00018
• Device Sequence Number: 1543576
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 0100020451570815
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/23/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Distributor Facility Aware Date: 12/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2016
• Initial Report FDA Received Date: 01/23/2017
• 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