BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4874747 · Received June 22, 2015

    Report

    Report Number
    3009974348-2015-00131
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 29, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PROD WAS EVALUATED FOR EVIDENCE OF ALLEGATION. THE RETURNED AMEDA PURELY YOURS BREAST PUMP MET AMEDA SPECIFICATIONS FOR BOTH SUCTION AND SPEED, AND PASSED VISUAL INSPECTION STANDARDS. NO EVIDENCE OF MALFUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC'S QUAL MGMT SYS 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 USED AT WORK WAS LOW SUCTION AND THEREFORE DECREASED MILK OUTPUT. THIS RESULTED IN MILK STASIS WITHIN THE BREASTS, PARTICULARLY THE RIGHT BREST. CUSTOMER WAS DIAGNOSED WITH RIGHT BREAST MASTITIS ON (B)(6) 2014 AFTER CONTACTING HER HEALTH CARE PROVIDER WITH SYMPTOMS OF A BREAST INFECTION THAT DAY. CUSTOMER WAS PRESCRIBED ORAL ANTIBIOTICS AND USED A HOSPITAL GRADE BREAST PUMP TO RESOLVE THE BREAST INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402653 PURELY YOURS ELECTRIC BREAST PUMP 884.5160 HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1