BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10378070 · Received August 7, 2020

    Report

    Report Number
    1419937-2020-00079
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 14, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451379807
    PMA / PMN Number
    K191653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND POWER CORD/SUPPLY AND RETURN OF HER PRODUCT WAS REQUESTED FOR EVALUATION. IN FOLLOW UP WITH THE CUSTOMER ON 07/22/2020, THE CUSTOMER INDICATED THAT WHEN THE SMOKING/MELTING OCCURRED, THE PUMP WAS PLUGGED INTO A WALL OUTLET USING THE POWER CORD/SUPPLY WHICH CAME WITH THE PUMP. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS, INCLUDING IN WRITING, TO FOLLOW UP REGARDING RETURN OF THE PRODUCT, WITH NO RESPONSE. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY MEDELA AG, THE LEGAL MANUFACTURER IN (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE FREESTYLE FLEX BREAST PUMP STARTED SMOKING WHERE THE POWER CORD ATTACHES TO THE PUMP BODY, CAUSING MELTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847090 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 163794 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1