BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 5021468 · Received August 12, 2015

    Report

    Report Number
    3009974348-2015-00167
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    December 12, 2013
    Report Date
    December 12, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS CONTACTED THREE TIMES AFTER THE INITIAL CONVERSATION. SHE WAS EVENTUALLY REACHED BY PHONE MONTHS LATER BUT DECLINED TO TROUBLESHOOT THE BREAST PUMP. AMEDA, INC. WAS UNABLE TO OBTAIN THE CUSTOMER'S MAILING ADDRESS, EMAIL ADDRESS AND THE PUMP'S SERIAL NUMBER. TO DATE, THE PUMP HAS NOT BEEN RETURNED TO AMEDA, INC., THEREFORE NO VISUAL INSPECTION OR ENGINEERING INVESTIGATION COULD BE PERFORMED.

    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) 2013 TO REPORT THAT WHILE USING THE PURELY YOURS BREAST PUMP, SHE NOTED SMOKE COMING FROM THE PUMP BASE NEAR THE AC ADAPTER PORT. SHE STATES THE PUMP'S MOTOR WAS MAKING A WEIRD NOISE AT THE SAME TIME. CUSTOMER DENIES ANY INJURY OR PROPERTY DAMAGE WHEN SMOKE WAS EMITTED FROM THE PUMP BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529729 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1