BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS ULTRA

    MDR report key: 5018603 · Received August 5, 2015

    Report

    Report Number
    3009974348-2015-00112
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    December 1, 2014
    Report Date
    December 1, 2014
    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

    CUSTOMER UNDERSTANDS THAT HER BREAST PUMP WAS OUT OF WARRANTY. AMEDA, INC. THEREFORE DID NOT REPLACE THE BREAST PUMP. CUSTOMER AGREED TO RETURN THE PURELY YOURS ULTRA TO AMEDA, INC. FOR INVESTIGATION AND WAS SENT AN EXPEDITED (B)(4) RETURN LABEL. AS OF THIS DATE, THE BREAST PUMP HAS NOT BEEN RETURNED TO AMEDA, INC.

    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) 2014 TO REPORT USING HER 3 YEAR OLD PURELY YOURS ULTRA BREAST PUMP WITH BATTERIES WHILE TRAVELING. SHE STATES SHORTLY AFTER INSTALLING 6 AA BATTERIES INTO THE BATTERY COMPARTMENT, PAUSING DURING THE PUMP'S CYCLING WAS NOTED AND THE MOTOR SOUNDED ROUGH. WHEN THE CUSTOMER OPENED THE BATTERY COMPARTMENT, SHE NOTICED GREY FLUID COMING FROM THE INSIDE OF THE BATTERY COMPARTMENT. CUSTOMER DID NOT COME IN CONTACT WITH THIS FLUID THEREFORE SHE REPORTS NO INJURY OR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517852 PURELY YOURS ULTRA ELECTRIC BREAST PUMP HGX AMEDA INC. 24501879

    Patients

    Seq Age Sex Outcome Treatment
    1