BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4922027 · Received July 7, 2015

    Report

    Report Number
    3009974348-2015-00121
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    January 1, 2014
    Report Date
    January 31, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AMEDA, INC. DID NOT ASK FOR THE PURELY YOURS MOTOR BASE BE RETURNED FOR INVESTIGATION SINCE IT PASSED ALL TESTING WITH CUSTOMER SERVICE. CUSTOMER REPLACED PUMP PIECES THAT IMPROVED THE FUNCTION OF THE BREAST PUMP.

    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 01/31/2014 TO REPORT LOW SUCTION AND DECREASED MILK OUTPUT WHEN PUMPING WITH THE PURELY YOURS BREAST PUMP. CUSTOMER REPORTS HER BREASTS DO NOT FEEL WELL DRAINED RESULTING IN CLOGGED MILK DUCTS AND EVENTUALLY MASTITIS. CUSTOMER WAS PRESCRIBED A 7 DAY COURSE OF ANTIBIOTICS AFTER BEING DIAGNOSED WITH MASTITIS BY HER HEALTH CARE PROVIDER. MASTITIS RESOLVED AND CUSTOMER FELT WELL WITHIN A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440159 PURELY YOURS ELECTIRC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other