BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4853016 · Received June 10, 2015

    Report

    Report Number
    3009974348-2015-00111
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED MOTOR UNIT WAS TESTED AT SEVERAL DIFFERENT SPEEDS AND SUCTION LEVELS. ALL VACUUM MEASUREMENTS WERE WITHIN SPECIFICATION. THE ALLEGATION WAS NOT REPEATED AND NO EVIDENCE OF MALFUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC'S QUALITY MGMT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACT AMEDA, INC TO REPORT THE PURELY YOURS BREAST PUMP SHE USES HAS EXPERIENCED LOW SUCTION DESPITE REPLACING MANY OF THE PUMP PIECES. LOW SUCTION HAS RESULTED IN DECREASED MILK OUTPUT AND THEN MASTITIS DUE TO MILK STASIS IN THE BREASTS. CUSTOMER CONTACTED HER HEALTH CARE PROVIDER AND WAS PRESCRIBED AN ORAL ANTIBIOTIC TO TREAT THE BREAST INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380400 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other