BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5161783 · Received October 20, 2015

    Report

    Report Number
    3009974348-2015-00174
    Event Type
    Injury
    Date Received
    October 20, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 22, 2015
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED FOUR TIMES, TWICE BY EMAIL AND TWICE BY PHONE REQUESTING RETURN OF THE PURELY YOURS BREAST PUMP BASE TO AMEDA, INC. FOR INVESTIGATION. AS OF THIS DATE, CUSTOMER HAS NOT RESPONDED TO EMAILS OR VOICE MAIL MESSAGES.THE PURELY YOURS PUMP BASE HAS NOT BEEN RETURNED TO AMEDA AS REQUESTED SO A VISUAL INSPECTION AND INVESTIGATION COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2015 TO REPORT LOW SUCTION AND DECREASED MILK OUTPUT WHEN USING THE PURELY YOURS BREAST PUMP. THIS ISSUE RESULTED IN BREAST ENGORGEMENT, CLOGGED MILK DUCTS AND EVENTUALLY LEFT BREAST MASTITIS. MASTITIS WAS DIAGNOSED BY HER HEALTH CARE PROVIDER ON (B)(6) 2015. SHE WAS PRESCRIBED A 10 DAY COURSE OF ORAL ANTIBIOTICS TO TREAT THE INFECTION AND AMEDA, INC. REPLACED HER BREAST PUMP. SHE REPORTS THE INFECTION IMPROVED WITHIN 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692092 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other