BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4871798 · Received June 16, 2015

    Report

    Report Number
    3009974348-2015-00122
    Event Type
    Injury
    Date Received
    June 16, 2015
    Date of Event
    February 10, 2014
    Report Date
    February 13, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PURELY YOURS PUMP WAS SENT TO CUSTOMER ON (B)(6) 2014 WITH INSTRUCTIONS TO SEND BACK THE PURELY YOURS PUMP THAT SHE HAD BEEN USING TO AMEDA FOR INVESTIGATION. A (B)(6) RETURN LABEL WAS PROVIDED FOR RETURN SHIPMENT. AS OF THIS DATE, THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC.'S QUALITY MGMT 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) 2014 TO REPORT LOW SUCTION AND DECREASED MILK OUTPUT WHEN SHE USES THE PURELY YOURS BREAST PUMP. CUSTOMER STATES PUMP DOES NOT EMPTY THE BREAST. CUSTOMER REPORTS RIGHT BREAST MASTITIS OCCURRED 3 TIMES IN 7 WKS. CUSTOMER EXCLUSIVELY USES THE PURELY YOURS PUMP TO EXPRESS HER MILK ON THE RIGHT BREAST DUE TO BABY'S INABILITY TO LATCH PROPERLY TO THIS BREAST. CUSTOMER IS BEING TREATED WITH ANTIBIOTICS FOR INFECTION. SHE USES OTHER INTERVENTIONS TO FURTHER DRAIN MILK PROPERLY FROM AFFECTED BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391460 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other