MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number	57063
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent a replacement breast pump.On 04/21/2017 a medela clinician followed up with the customer at which time she stated that she was diagnosed and treated by her physician for mastitis.She was prescribed dicloxacillin 500mg for 10 days.She also stated that the issue is 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 was received on 04/19/2017, and inspected by quality engineering at which time a malfunction was found, but the customer's complaint of low suction was not confirmed.
Event or Problem Description
On (b)(6) 2017, the customer reported to customer service that suction on her pump in style advanced breast pump was low.She also stated that she had mastitis.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; mchenry IL
• MDR Report Key: 6523038
• Report Number: 1419937-2017-00122
• Device Sequence Number: 18951474
• Product Code: HGX
• UDI-Device Identifier: 00020451570631
• UDI-Public: (01)00020451570631
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/26/2017

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: 57063
• Device Catalogue Number: 57063
• Device Lot Number: 429585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Distributor Facility Aware Date: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 04/26/2017
• 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