MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE RETAIL EN FR ES (YELLOWFIN); PUMP, BREAST, POWERED

Model Number	101041361
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
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 on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.
Event or Problem Description
On (b)(6) 2022, the customer alleged to medela llc that her pump in style max flow breast pump caught fire while plugged into a wall outlet.

• Brand Name: PUMP IN STYLE RETAIL EN FR ES (YELLOWFIN)
• 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: 13686385
• Report Number: 1419937-2022-00023
• Device Sequence Number: 17469965
• Product Code: HGX
• UDI-Device Identifier: 00020451401454
• UDI-Public: 020451401454
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200508
• 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): 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 101041361
• Device Catalogue Number: 101041361
• Device Lot Number: 0000032631
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/08/2022
• Date Device Manufactured: 10/01/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Female