MAUDE Adverse Event Report: MEDELA LLC SONATA DELUXE SINGLE PACK; PUMP, BREAST, POWERED

Model Number	58200
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.The customer was contacted by a complaint handler to get additional information, with no response as of the date of this report.Based on the results of (b)(4), it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is (b)(4)% for the period of january 2013 to august 2017."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) 2018, the customer alleged to medela (b)(4) that when she took her sonata breast pump out of the box, the housing was misaligned and when she plugged the tubing in, the housing came apart and broke the tubing.She further alleged that both she and her baby slept through the night, she got mastitis in the morning and was not able to use the pump because of the broken tubing and misaligned housing.She saw her doctor who prescribed her an antibiotic for the mastitis, which is almost resolved.
Additional Manufacturer Narrative
In follow up with a complaint handler on (b)(6) 2018, the customer indicated that she developed mastitis on (b)(6) 2018 and was prescribed an antibiotic.She indicated that the replacement pump was working without issue and the mastitis has since resolved.

• Brand Name: SONATA DELUXE SINGLE PACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 7428273
• Report Number: 1419937-2018-00106
• Device Sequence Number: 19262052
• Product Code: HGX
• UDI-Device Identifier: 00020451582009
• UDI-Public: (01)00020451582009
• Combination Product (Y/N): N
• Initial Reporter State: NC
• PMA/510(K) Number: K161725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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: 58200
• Device Catalogue Number: 58200
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 04/30/2018
• 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