BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4932665 · Received July 15, 2015

    Report

    Report Number
    3009974348-2015-00087
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    October 11, 2013
    Report Date
    November 19, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED BECAUSE INCOMPLETE DEVICE WAS RETURNED. ALL RETURNED PIECES VISUALLY MET SPECIFICATIONS EXCEPT FOR 1 WHITE VALVE WHICH WAS TORN.

    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 PAIN AND DECREASED MILK OUTPUT WHILE USING THE PURELY YOURS BREAST PUMP AT HOME. CUSTOMER ALSO USES HOSPITAL GRADE BREAST PUMP WHEN PUMPING AT THE HOSPITAL WHICH PROVIDES GREATER EFFICIENCY IN BREAST MILK EXPRESSION. CUSTOMER WAS DIAGNOSED WITH UNILATERAL MASTITIS APPROX. 4-6 WEEKS BEFORE CONTACTING AMEDA. MASTITIS RESOLVED WITH ORAL ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460860 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other