BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 5484952 · Received March 7, 2016

    Report

    Report Number
    3009974348-2016-00197
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Date of Event
    February 10, 2016
    Report Date
    February 10, 2016
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AMEDA, INC HAS ATTEMPTED TO CONTACT THE CUSTOMER TWICE BY PHONE AND ONCE BY EMAIL ON (B)(6) 2016 RESPECTIVELY. CUSTOMER WAS LEFT VOICE MAIL AND EMAIL MESSAGES INFORMING HER TO RETURN THE PURELY YOURS BREAST PUMP FOR INVESTIGATION USING THE PREPAID(B)(6) RETURN LABEL SENT TO HER EMAIL ADDRESS. AS OF THIS DATE, THE BREAST PUMP HAS NOT BEEN RETURNED TO AMEDA, INC FOR INVESTIGATION, THEREFORE A VISUAL INSPECTION COULD NOT BE CONDUCTED. IF THIS PUMP PRODUCT IS RETURNED TO AMEDA, INC. AFTER MEDWATCH IS FILED WITH THE FDA, A SUPPLEMENTAL MEDWATCH WILL BE FILED AFTER THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2016 TO REPORT BLACK FLUID LEAKING FROM THE BATTERY COMPARTMENT WHILE SHE WAS USING THE PURELY YOURS BREAST PUMP ON BATTERY POWER THAT MORNING. SHE REPORTS A BURNING SMELL AS THIS OCCURRED HOWEVER SHE DID OBSERVE ANY SMOKE OR FLAME. CUSTOMER USES THE BREAST PUMP ONLY ONCE/WEEK. SHE DENIES COMING IN CONTACT WITH THE LEAKING FLUID AND STATES NO PROPERTY DAMAGE, INJURY OR BURN FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141046 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR