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

Model Number 101041361

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

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 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)
• Type of Device: 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
• MDR Text Key: 289317821
• Report Number: 1419937-2022-00023
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451401454
• UDI-Public: 020451401454
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/15/2022
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female