MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number	57062
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A replacement breast pump was sent to the customer.On (b)(6) 2017, a medela clinician followed up with the customer, at which time she stated she finished her prescription for dicloxicillin to treat mastitis and it has resolved.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.The product involved in the complaint was not returned for evaluation/investigation.Therefore, no conclusions can be made as to the cause of the event.
Event or Problem Description
On (b)(6) 2017, the customer reported to customer service that the tubing connector for her pump in style advanced breast pump was damaged and it affected the suction.On (b)(6) 2017, when responding to a request to return the product, the customer indicated that she developed mastitis.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL
• MDR Report Key: 6560118
• Report Number: 1419937-2017-00137
• Device Sequence Number: 13705797
• Product Code: HGX
• UDI-Device Identifier: 00020451570624
• UDI-Public: (01)00020451570624
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/11/2017

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: 57062
• Device Catalogue Number: 57062
• Device Lot Number: (10)434100
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/11/2017
• 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