BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4871986 · Received June 3, 2015

    Report

    Report Number
    3009974348-2015-00100
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED BREAST PUMP FUNCTIONED WITHIN AMEDA SPECIFICATIONS. INVESTIGATION CONCLUDED THAT THE INTERNAL COMPONENTS OF THE BREAST PUMP DISPLAYED NO EVIDENCE OF MALFUNCTION OR THERMAL EVENT. IT WAS VISUALLY CONFIRMED THAT A DARK GREY SUBSTANCE RESEMBLING BATTERY ACID WAS PRESENT ON THE EXTERNAL PUMP HOUSING, BATTERY COMPARTMENT AREA, AND BATTERY COVER. BECAUSE THE BATTERIES WERE NOT RETURNED, ENGINEERING CANNOT CONFIRM IF A BATTERY PLACED IN THE PUMP LEAKED. ADDITIONAL TESTING SUPPORTS THAT THE MISPLACEMENT OF A BATTERY CAN CAUSE BATTERY LEAKAGE.

    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 THAT THE BATTERIES INSIDE THE BATTERY COMPARTMENT EXPLODED DURING PUMPING WITH THE PURELY YOURS BREAST PUMP. CUSTOMER DENIED INJURY OR BURN WHEN THIS EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358671 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1