BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4871989 · Received June 3, 2015

    Report

    Report Number
    3009974348-2015-00094
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE VOICE MAIL MESSAGES WERE LEFT WITH THE CUSTOMER ASKING HER TO RETURN THE PUMP BASE TO AMEDA, INC. FOR INVESTIGATION USING THE EXPEDITED FEDEX RETURN LABEL PREVIOUSLY SENT TO HER. TO DATE, THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC'S QUALITY MANAGEMENT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) /2014, TO REPORT A BURNING SMELL, A SMALL AMOUNT OF SMOKE AND LEAKING BLACK FLUID COMING FROM THE BATTERY COMPARTMENT OF THE PURELY YOURS BREAST PUMP DURING USE WITH BATTERIES. CUSTOMER STATES SHE DID NOT COME IN CONTACT WITH THE FLUID AND REPORTS NO INJURY OR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358672 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1