BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 6391401 · Received March 9, 2017

    Report

    Report Number
    3009974348-2017-00254
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    February 9, 2017
    Report Date
    February 10, 2017
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS TESTED PER AMEDA ENGINEERING PROTOCOL TO DETERMINE WHETHER THE ALLEGATION OF LEAKING FLUID COULD BE CONFIRMED. THE RETURNED PRODUCT WAS ASSESSED FOR INDICATIONS OF MALFUNCTION OR THERMAL EVENT. THE RETURNED PRODUCT WAS ASSESSED FOR FUNCTIONALITY AND MET FUNCTIONAL SPECIFICATIONS WITH KNOWN AC ADAPTER. DARK GREY SUBSTANCE, E.G BATTERY ACID, WAS OBSERVED INSIDE THE BATTERY COMPARTMENT. INTERNALLY, NO SIGNS OF FOREIGN SUBSTANCE, BURNING, MELTING WERE OBSERVED. THE RETURNED BATTERIES WERE OBSERVABLY DAMAGED. ADDITIONAL TESTING CONFIRMED THAT BATTERIES MAY LEAK WHEN THE UPPER MIDDLE BATTERY IS PLACED INCORRECTLY, WITH THE POSITIVE AND NEGATIVE END REVERSED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON 02/10/2017 TO REPORT CLEAR FLUID LEAKING FROM THE BATTERY COMPARTMENT OF HER PURELY YOURS BREAST PUMP WHILE PUMPING ON BATTERY POWER. THIS EVENT OCCURRED ON (B)(6) 2017 WHILE IN THE CUSTOMER'S CAR. SHE REPORTS HEARING A SIZZLE SOUND INSIDE THE PUMP BASE FOLLOWED BY DECREASED SUCTION THEN CLEAR FLUID LEAKING FROM THE BASE. CUSTOMER'S RIGHT POINTER FINGER CAME IN CONTACT WITH THIS FLUID RESULTING IN A CHEMICAL BURN. SHE STATES WASHING HER HANDS IMMEDIATELY, DID NOT APPLY ANY MEDICATION OR CONTACT HER HEALTHCARE PROVIDER. CUSTOMER WAS SENT A REPLACEMENT PURELY YOURS PUMP BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172765 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other