BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4846696 · Received June 12, 2015

    Report

    Report Number
    3009974348-2015-00113
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    January 23, 2014
    Report Date
    January 27, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT THE NECESSARY PUMP PIECES TO CORRECT THE ISSUES WITH THE PURELY YOURS BREAST PUMP. PURELY YOURS MOTOR BASE WAS NOT REQUESTED BACK FOR INVESTIGATION SINCE ALL MOTOR TESTS CONDUCTED THROUGH CUSTOMER SERVICE PASSED. NO PRODUCT HAS BEEN RETURNED TO AMEDA, INC. FOR TESTING.

    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) 2014 TO REPORT LOW SUCTION AND HISSING SOUNDS ORIGINATING SOMEWHERE WITHIN THE SYSTEM WHILE USING THE PURELY YOURS BREAST PUMP. CUSTOMER WAS DIAGNOSED WITH UNILATERAL MASTITIS ON (B)(6) 2014. SHE CONTACTED HER HEALTH CARE PROVIDER THAT DAY. A 10 DAY COURSE OF ORAL ANTIBIOTICS WAS PRESCRIBED. CUSTOMER REPORTS MASTITIS RESOLVED WITHIN 3 DAYS OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383753 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other