BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5088915 · Received September 18, 2015

    Report

    Report Number
    3009974348-2015-00169
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 21, 2015
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS TESTED BY AMEDA ENGINEERING. SUCTION WAS TESTED AT SIX DIFFERENT SETTINGS. CYCLE RATE WAS CONCURRENTLY OBSERVED AND VISUALLY COMPARED TO THE PROCEDURE. CYCLE RATE WAS OBSERVED TO BE NONCONFORMING AND VACUUM MEASUREMENTS WERE NOT WITHIN SPECIFICATION FOR 2 OF THE 6 SETTINGS. RETURNED UNIT WAS INVESTIGATED VIA DISASSEMBLY FOR ROOT CAUSE AND FOUND DEFECTS WITHIN THE CIRCUIT BOARD.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2015 TO REPORT THE PURELY YOURS BREAST PUMP SHE EXCLUSIVELY USES TO EXPRESS BREAST MILK FOR HER BABY BEGAN DECLINING IN FUNCTION SEVERAL WEEKS AGO WITH LOWER SUCTION, LESS MILK OUTPUT, CLOGGED MILK DUCTS AND ENGORGED BREASTS. THIS EVENTUALLY LED TO RIGHT BREAST MASTITIS ON (B)(6) 2015. CUSTOMER WAS PRESCRIBED A 10 DAY COURSE OF ORAL ANTIBIOTICS FROM HER HEALTHCARE PROVIDER ON (B)(6) 2015. SHE RECENTLY COMPLETED THE COURSE OF MEDICATION AND FEELS GREAT IMPROVEMENT IN HEALTH. CUSTOMER PUMPED MORE FREQUENTLY WITH A REPLACEMENT PURELY YOURS PUMP SENT TO HER AFTER SHE CONTACTED AMEDA, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619035 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other