BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE RETAIL EN FR ES (YELLOWFIN)

    MDR report key: 13686385 · Received March 8, 2022

    Report

    Report Number
    1419937-2022-00023
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 7, 2022
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451401454
    PMA / PMN Number
    K200508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445387 PUMP IN STYLE RETAIL EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041361 0000032631 00020451401454

    Patients

    Seq Age Sex Outcome Treatment
    1 Female