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

Model Number	58200
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer including disassembling, inspecting, cleaning and reassembling the kit and tubing, but it did not resolve the suction issue.A replacement pump was sent to the customer.The customer was contacted by a complaint handler and she responded on 07/27/2017, status that she had blistering and bleeding and saw a physician, who prescribed an ointment.The pain has now been resolved for the most part, but she has sensitive nipples and scarring from previous pumping and babies.The pump was received and evaluated with a lab kit and tubing and passed all functional tests.See attached evaluation.
Event or Problem Description
On (b)(6)2017, the customer alleged that she had low suction with her sonata breast pump and that the battery was not holding a charge.She stated that when breastfeeding she had a lot of pain because her twins did not latch on properly, so she started using the sonata instead and experienced some pain, but it was not as bad as when she breastfed.She was given some cream but no medication.She has scar tissue and it is painful as well.The customer alleged that she did see a doctor and he told her she could stop using the cream since she was healed.

• 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: 6822476
• Report Number: 1419937-2017-00237
• Device Sequence Number: 851769
• Product Code: HGX
• UDI-Device Identifier: 00020451582009
• UDI-Public: (01)00020451582009
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 08/25/2017

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: 58200
• Device Catalogue Number: 58200
• Device Lot Number: (10) 432570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Distributor Facility Aware Date: 06/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/25/2017
• 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