BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4943568 · Received July 22, 2015

    Report

    Report Number
    3009974348-2015-00155
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PURELY YOURS BREAST PUMP WITH AC ADAPTER WAS SENT TO CUSTOMER ON 06/09/2014. CUSTOMER WAS SENT A (B)(6) RETURN LABEL FOR SHIPMENT BACK TO AMEDA, INC. FOR INVESTIGATION OF COMPLAINT. PURELY YOURS MOTOR BASE AND AC ADAPTER WERE NOT RETURNED DESPITE CONTACTING THE CUSTOMER SEVERAL TIMES.

    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 06/09/2014 TO REPORT THE PURELY YOURS BREAST PUMP SHE USES EXCLUSIVELY TO EXPRESS HER BREAST MILK FOR HER INFANT FOR THE PAST 6 MONTHS, ELICITED A BURNING SMELL, MOTOR BASE BECAME HOT AND SHE NOTED SMOKE COMING FROM THE AC ADAPTER NEAR THE PLUG. CUSTOMER REPORTS NO INJURY OR BURN OCCURRED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474303 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1