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	01/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent a replacement pump to help resolve the issue along with 21 mm breastshields.The customer was contacted on (b)(6) 2017, and the customer stated that she was diagnosed on (b)(6) 2017 with mastitis and prescribed clindamycian and took it for 10 days, the mastitis has now been resolved.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 ir14-(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 on (b)(6) 2017 that is sounds like her pump in style skips in both phases.She also indicated that she had mastitis 1 1/2 months ago and her doctor prescribed her antibiotics.

• Brand Name: BREASTPUMP PNSA STARTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; mchenry IL
• MDR Report Key: 6372224
• Report Number: 1419937-2017-00063
• Device Sequence Number: 19084696
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: (01)00020451570815
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/02/2017

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: 02/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/02/2017
• 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