BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4871957 · Received June 3, 2015

    Report

    Report Number
    3009974348-2015-00103
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS PROVIDED INSTRUCTIONS AND A PRE-PAID RETURN (B)(6) LABEL TO SHIP BACK THE DEFECTIVE BREAST PUMP TO AMEDA, INC. TO DATE, THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA FOR EVALUATION.

    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 THE FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2014, TO REPORT A BURNING SMELL AND LEAKING BLACK FLUID FROM THE BATTERIES IN THE BATTERY COMPARTMENT WHILE USING THE PURELY YOURS BREAST PUMP. CUSTOMER STATES SHE HAD NO CONTACT WITH THE BLACK FLUID LEAKING FROM THE HOUSING, THEREFORE, SHE DID NOT SUSTAIN AN INJURY OR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358775 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1