BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4882688 · Received June 25, 2015

    Report

    Report Number
    3009974348-2015-00097
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 27, 2015
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS EVALUATED FOR EVIDENCE OF ALLEGATION. THE RETURNED AMEDA PURELY YOURS BREAST PUMP MET AMEDA SPECS FOR BOTH SUCTION AND SPEED, AND PASSED VISUAL INSPECTION STANDARDS. NO EVIDENCE OF MALFUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2015 TO REPORT LOW SUCTION AND DECREASED MILK OUTPUT WHILE USING THE PURELY YOURS BREAST PUMP THAT HAS BEEN ONGOING FOR WEEKS. CUSTOMER STATES SHE USED THE PURELY YOURS PUMP MORE FREQUENTLY PRIOR TO A DIAGNOSIS OF UNILATERAL RIGHT BREAST MASTITIS ON (B)(6) 2015. DUE TO BABY'S CONGESTION FROM A COLD AND HIS INABILITY TO NURSE, MOM USED THE PURELY YOURS PUMP EXCLUSIVELY EARLIER IN THE MONTH. CUSTOMER CONTACTED HER HEALTH CARE PROVIDER ON (B)(6)2015 AND WAS PRESCRIBED A 10 DAY COURSE OF ANTIBIOTICS. CUSTOMER FELT WELL WITHIN 3 DAYS SO SHE STOPPED THE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410788 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other