BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4950056 · Received July 24, 2015

    Report

    Report Number
    3009974348-2015-00158
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PURELY YOURS MOTOR BASE WAS NOT REQUESTED BACK FOR INVESTIGATION SINCE ALL MOTOR TESTS CONDUCTED BY AMEDA 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. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2014 TO REPORT THE PURELY YOURS BREAST PUMP SHE USES EXCLUSIVELY TO EXPRESS MILK FOR HER INFANT IN NICU, HAS DECREASED SUCTION WHICH RESULTED IN DECREASED MILK OUTPUT, ENGORGEMENT AND UNILATERAL MASTITIS. CUSTOMER HAS REPLACED NUMEROUS PUMP PIECES TRYING TO RESOLVE THIS ISSUE BUT THE LOW SUCTION ISSUE AND ENGORGEMENT CONTINUED TO OCCUR. CUSTOMER CONTACTED HER HEALTH CARE PROVIDER AND WAS PRESCRIBED ORAL ANTIBIOTICS TO RESOLVE THE INFECTION. CUSTOMER WAS INFORMED BY AMEDA CUSTOMER SERVICE TO RENT A HOSPITAL GRADE BREAST PUMP AS THIS TYPE OF PUMP IS INDICATED WHEN HER BABY IS IN THE NICU AND UNABLE TO NURSE AT THE BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483417 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other