MAUDE Adverse Event Report: MEDELA LLC SWING MAXI; PUMP, BREAST, POWERED

Model Number	101043614
Date of Event	02/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 02/24/2022, the customer called and spoke with customer service and stated she didn't want to use the swing maxi pump and didn't want to troubleshoot.She would like a pump in style as her replacement pump.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 02/24/2022, the customer indicated that she developed clogged ducts and milk blisters and was prescribed medication.She stated her clogged ducts are reoccurring and she is being diligent to express as often and long but is using her previous pump in style breast pump.The device was returned with the customer's parts and accessories and was evaluated on 03/11/2022.The device passed suction and cycle specifications.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On (b)(6) 2022, the customer emailed medela llc and alleged that her recently purchased swing maxi breast pump she used for a full day and night was painful and caused clogged ducts.She went to the hospital due to her breast being hard.

• Brand Name: SWING MAXI
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 13763723
• Report Number: 1419937-2022-00026
• Device Sequence Number: 5033030
• Product Code: HGX
• UDI-Device Identifier: 00020451436142
• UDI-Public: 020451436142
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K210759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 101043614
• Device Catalogue Number: 101043614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Distributor Facility Aware Date: 02/24/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse