BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 7781269 · Received August 14, 2018

    Report

    Report Number
    3009974348-2018-00324
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    June 30, 2018
    Report Date
    July 16, 2018
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    UDI-DI
    00810725021477
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PURELY YOURS PUMP WAS TESTED PER AMEDA ENGINEERING PROTOCOL TO DETERMINE WHETHER THE ALLEGATION OF LEAKING FLUID COULD BE CONFIRMED. IT WAS ASSESSED FOR INDICATIONS OF MALFUNCTION OR THERMAL EVENT. IT WAS ALSO ASSESSED FOR FUNCTIONALITY AND MET FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2018 TO REPORT THAT WHILE USING 6 AA BATTERIES TO POWER ON HER PURELY YOURS BREAST PUMP 2 WEEKS AGO, SHE HEARD A STRANGE GURGLING SOUND FOLLOWED BY CLEAR BLUISH FLUID THAT LEAKED FROM THE BATTERY COMPARTMENT ONTO HER HANDS. SHE STATES THE FLUID WAS WARM AND HER HANDS TINGLED BUT SHE DID NOT GET BURNED OR INJURED. SHE STATES NO REDNESS OR BLISTERS OCCURRED. CUSTOMER DID NOT SEEK MEDICAL ATTENTION AFTER THE EVENT. SHE HAD PUMPED ONE OTHER TIME WITH THE SAME BATTERIES BEFORE THIS EVENT OCCURRED. A REPLACEMENT BREAST PUMP WAS SHIPPED OVERNIGHT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621205 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082 00810725021477

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR