BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4846913 · Received June 12, 2015

    Report

    Report Number
    3009974348-2015-00117
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    August 5, 2013
    Report Date
    August 12, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A REPLACEMENT PURELY YOURS BREAST PUMP ON 08/12/2013 AND WAS ASKED TO RETURN THE ORIGINAL BREAST PUMP TO AMEDA, INC FOR EVALUATION. AN EXPEDITED (B)(6) RETURN SHIPPING LABEL WAS PROVIDED FOR PRODUCT RETURN. THOUGH REQUESTED, THE REPORTED PRODUCT WAS NOT 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 FDA. CUSTOMER CONTACTED AMEDA, INC. ON 08/12/2013 TO REPORT BLACK FLUID COMING OUT OF THE BATTERY COMPARTMENT OF THE PURELY YOURS BREAST PUMP DURING USE. CUSTOMER STATES SHE WAS UNCERTAIN WHERE THE BLACK FLUID WAS LEAKING FROM, THE MOTOR ITSELF OR THE BATTERY COMPARTMENT. CUSTOMER STATES NO INJURY OR BURN WHEN THIS EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383907 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1