BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4844240 · Received June 2, 2015

    Report

    Report Number
    3009974348-2015-00093
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE PHONE CALLS WERE PLACED TO THE CUSTOMER REQUESTING THE PRODUCT BE RETURNED TO AMEDA, INC. FOR INVESTIGATION USING THE PRE-PAID (B)(6) RETURN LABEL SENT TO HER. TO DATE, THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC. FOR EVALUATION.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC'S QUALITY MANAGEMENT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO THE FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2014 TO REPORT THE PURELY YOURS ULTRA BREAST PUMP HAD BEEN LOSING SUCTION OVER TIME AND TODAY LEAKED DARK FLUID FROM THE BATTERY COMPARTMENT WHILE USING IT WITH BATTERIES. CUSTOMER REPORTS THE FLUID STAINED HER COUCH AND CLOTHES BUT SHE DID NOT COME INTO CONTACT WITH THE FLUID. CUSTOMER DENIES INJURY OR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356777 PURELY YOURS ELECTRIC BREAST PUMP 884.5160 HGX AMEDA, INC. 24501879

    Patients

    Seq Age Sex Outcome Treatment
    1