BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4871958 · Received June 3, 2015

    Report

    Report Number
    3009974348-2015-00096
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    February 16, 2014
    Report Date
    February 17, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A LETTER, ASKING FOR RETURN OF THE PURELY YOURS PUMP BASE TO AMEDA, INC. FOR EVALUATION OF THE PRODUCT. A PRE-PAID FEDEX RETURN LABEL WAS SENT IN THE BOX WITH THE NEW PRODUCT ON (B)(6) 2014 FOR RETURN SHIPMENT. TO DATE, THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC.

    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 BATTERIES LEAKED INSIDE THE BATTERY COMPARTMENT OF THE PURELY YOURS BREAST PUMP DURING USE ON (B)(6) 2014. IT IS NOT UNKNOWN IF THE CUSTOMER BURNED HERSELF FOR THIS, WAS NOT CLARIFIED IN THE CASE FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360204 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1