BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4943578 · Received July 22, 2015

    Report

    Report Number
    3009974348-2015-00152
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    November 15, 2013
    Report Date
    November 15, 2013
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, THE REPORTED PRODUCT WAS NOT RETURNED, THEREFORE, NO VISUAL INSPECTION AND NO FUNCTIONAL TESTING COULD BE PERFORMED.

    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 FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2013 TO REPORT A SHOCK SENSATION UPON PLUGGING IN THE AC ADAPTER KNOWING THE AC ADAPTER WIRES WERE EXPOSED. CUSTOMER REPORTS NO INJURY OR BURN. SHE DID NOT SEEK MEDICAL ATTENTION IN THIS MATTER. PURELY YOURS PUMP AND AC ADAPTER WERE OUT OF WARRANTY, HOWEVER AMEDA, INC. REPLACED THE AC ADAPTER FOR THIS CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476711 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1