BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4922034 · Received July 9, 2015

    Report

    Report Number
    3009974348-2015-00085
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    November 15, 2013
    Report Date
    November 15, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP. THE RETURNED PRODUCT WAS INVESTIGATED AND CYCLE RATE WAS OBSERVED TO BE NONCONFORMING. ALSO, VACUUM MEASUREMENTS WERE NOT WITHIN SPECIFICATION DUE TO A BROKEN BELT. BROKEN BELTS ARE A KNOWN WEAR PROBLEM. THE DESIGN ENHANCEMENT WAS IMPLEMENTED VIA (B)(4) TO EXTEND EXPECTED LIFE.

    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 FDA. CUSTOMER CONTACTED AMENDA, INC. ON 11/15/2013 TO REPORT LOW SUCTION AND DECREASED MILK OUTPUT WHILE USING THE PURELY YOURS BREAST PUMP. THE CUSTOMER WAS ADVISED TO REPLACE SOME PUMP PARTS TO RESOLVE THE LOW SUCTION ISSUE. THE REPLACEMENT OF PUMP PARTS DID NOT RESOLVE THIS ISSUE. CUSTOMER WAS DIAGNOSED WITH A UNILATERAL RIGHT BREAST MASTITIS BY HEAR HEALTH CARE PROVIDER. CUSTOMER CONTACTED HER HEALTH CARE PROVIDER AND WAS PRESCRIBED ORAL ANTIBIOTICS WHICH RESOLVED THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447765 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other