BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4922035 · Received July 14, 2015

    Report

    Report Number
    3009974348-2015-00088
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    November 14, 2013
    Report Date
    November 19, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED BECAUSE INCOMPLETE DEVICE WAS RETURNED. ALL RETURNED PIECES VISUALLY MET SPECIFICATIONS EXCEPT FOR 4 WHITE VALVES WHICH WERE TORN.

    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 11/19/2013 TO REPORT LOW SUCTION, PAIN WITH PUMPING AND LOW MILK OUTPUT WHEN SHE USES THE PURELY YOURS BREAST PUMP COMPARED TO A HOSPITAL GRADE BREAST PUMP SHE USES WHILE VISITING HER HOSPITALIZED BABY. CUSTOMER STATES HER BREASTS BECAME VERY TENDER, SWOLLEN AND WARM STARTING ON (B)(6) 2013. CUSTOMER'S HEALTH CARE PROVIDER DIAGNOSED HER WITH MASTITIS AND PRESCRIBED A 10 DAY COURSE OF ORAL ANTIBIOTICS. MASTITIS SYMPTOMS RESOLVED WITHIN 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457753 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other