BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4943549 · Received July 17, 2015

    Report

    Report Number
    3009974348-2015-00147
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    August 29, 2013
    Report Date
    August 29, 2013
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PURELY YOURS BREAST PUMP WAS SENT TO THE CUSTOMER ON (B)(6) 2013. CUSTOMER WAS ASKED TO RETURN THE DEFECTIVE PUMP BACK TO AMEDA, INC. FOR INVESTIGATION BY USING THE FEDEX LABEL SENT TO HER. AS OF THIS DATE, THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA.

    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 SMELLING SMOKE THEN SEEING SMOKE COMING OUT OF THE MOTOR OF THE PURELY YOURS BREAST PUMP DURING USE. CUSTOMER REPORTS NO INJURY OR BURN OCCURRED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464686 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1