BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5006559 · Received August 7, 2015

    Report

    Report Number
    3009974348-2015-00083
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    October 10, 2013
    Report Date
    October 31, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOW SUCTION ALLERGAN WAS CONFIRMED. THIS WAS CAUSED BY A TORN ROLLING DIAPHRAGM IN THE BREAST PUMP INTERNAL PISTON ASSEMBLY.

    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 AMEDA, INC. ON (B)(6) 2013 TO REPORT LOW SUCTION AND POOR MILK OUTPUT WHILE USING THE PURELY YOURS BREAST PUMP DESPITE REPLACEMENT OF PUMP PIECES IN ATTEMPTS TO RESOLVE THE ISSUE. CUSTOMER EXCLUSIVELY PUMPS TO PROVIDE BREAST MILK FOR THE BABY. CUSTOMER HAS A HISTORY OF MASTITIS. SHE WAS RECENTLY AGAIN DIAGNOSED WITH UNILATERAL MASTITIS BY HER HEALTH CARE PROVIDER AND WAS TREATED WITH ORAL ANTIBIOTICS WITH GOOD RESOLUTION OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521260 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other