BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4950076 · Received July 24, 2015

    Report

    Report Number
    3009974348-2015-00136
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 25, 2015
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT 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

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2015 TO REPORT THE PURELY YOURS BREAST PUMP SHE BEGAN USING 2 DAYS PRIOR POWERS ITSELF OFF MIDWAY THROUGH THE PUMPING SESSION. CUSTOMER USED THE AMEDA AC ADAPTER AS THE POWER SOURCE TO THE BREAST PUMP. AMEDA'S CUSTOMER SERVICE REPRESENTATIVE INSTRUCTED CUSTOMER TO INSTALL 6 AA BATTERIES INTO THE BATTERY COMPARTMENT TO DETERMINE WHAT ACTION TO TAKE TO RESOLVE THIS ISSUE. CUSTOMER WAS INFORMED TO CALL BACK TO AMEDA WITH RESULTS. SHE DID NOT CALL BACK UNTIL (B)(6) 2015, REPORTING THE PURELY YOURS PUMP DOES NOT POWER ON WITH BATTERIES. BY THE EARLY MORNING HOURS ON (B)(6) 2015, CUSTOMER HAD DEVELOPED LEFT BREAST MASTITIS. CUSTOMER REPORTS NURSING HER BABY IS PAINFUL AND SHE RELIES ON THE BREAST PUMP TO EXPRESS BREAST MILK. CUSTOMER CONTACTED HER HEALTH CARE PROVIDER AND WAS PRESCRIBED A 7 DAY COURSE OF ORAL ANTIBIOTICS FOR THE BREAST INFECTION. CUSTOMER STATES FEELING HER HEALTH HAS IMPROVED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483508 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other