BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4871843 · Received June 17, 2015

    Report

    Report Number
    3009974348-2015-00119
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS PHONED 3 TIMES IN AN ATTEMPT TO COLLECT ADD'L INFO REGARDING PURELY YOURS BREAST PUMP CONCERNS AND MASTITIS. TO DATE, THE PURELY YOURS BREAST PUMP HAS NOT BEEN RETURNED TO AMEDA, INC. FOR INVESTIGATION.

    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 THE PURELY YOURS BREAST PUMP SHE USES BEGAN EXPERIENCING VERY LOW SUCTION AND DECREASED MILK OUTPUT. SUCTION REMAINED LOW DESPITE REPLACEMENT OF SOME PUMP PIECES. CUSTOMER REPORTS BEING DIAGNOSED WITH A BREAST INFECTON. HER HEALTH CARE PROVIDER PRESCRIBED ORAL ANTIBIOTICS TO TREAT THE MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394315 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other