BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5114627 · Received September 30, 2015

    Report

    Report Number
    3009974348-2015-00143
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    May 29, 2014
    Report Date
    June 12, 2014
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT WAS DISPOSED OF BY LAB TECHNICIAN. THIS ENGINEERING REVIEW IS BEING CONDUCTED BASED ON DATA COLLECTED FROM THE LAB COMPLAINT INVESTIGATION PROCEDURE. PRODUCT WAS EVALUATED FOR EVIDENCE OF ALLEGATION. THE RETURNED AMEDA PURELY YOURS BREAST PUMP MET AMEDA SPECIFICATIONS FOR BOTH SUCTION AND SPEED, AND PASSED VISUAL INSPECTION STANDARDS. NO EVIDENCE OF MALFUNCTION WAS OBSERVED.

    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 THE PURELY YOURS BREAST PUMP SHE USES HAS LOW SUCTION RESULTING IN DECREASED MILK OUTPUT AND MASTITIS. CUSTOMER WAS DIAGNOSED BY HER HEALTH CARE PROVIDER WITH UNILATERAL MASTITIS ON (B)(6) 2014 WHICH RESOLVED WITH ORAL ANTIBIOTICS, NURSING HER BABY MORE OFTEN AND REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646362 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other