BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5111165 · Received September 29, 2015

    Report

    Report Number
    3009974348-2015-00178
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    April 10, 2014
    Report Date
    April 17, 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

    PRODUCT WAS RECEIVED AT AMEDA AND EVALUATED FOR LOW SUCTION ON MAY 9, 2014. THE ALLEGATION WAS NOT CONFIRMED AND NO EVIDENCE OF MALFUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC.'S QUALITY MANAGEMENT SYSTEM ADDITIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACTED AMEDA, INC. ON 04/17/2014 TO REPORT LOW SUCTION AND POOR MILK OUTPUT WHEN USING THE PURELY YOURS BREAST PUMP. CUSTOMER DEVELOPED A BILATERAL MASTITIS DURING USE OF THE PURELY YOURS BREAST PUMP 1 WEEK AFTER DELIVERING HER THIRD BABY. CUSTOMER STATES WHEN SHE INCREASED THE DIAL SETTING FOR BOTH SUCTION AND SPEED, SHE DOES NOT FEEL A CHANGE AT THE BREAST. CUSTOMER CONTACTED HER HEALTH CARE PROVIDER WHO PRESCRIBED ORAL ANTIBIOTICS WHICH RESOLVED THE BREAST INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641249 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other