BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4922029 · Received July 7, 2015

    Report

    Report Number
    3009974348-2015-00140
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    May 19, 2014
    Report Date
    June 2, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED BREAST PUMP MET AMEDA SPECIFICATIONS WHEN USED AT MAXIMUM SPEED AND MAXIMUM SUCTION. THIS IS EVIDENCE THAT THE BREAST PUMP WAS FUNCTIONING AS DESIGNED. THE OUTPUT OF THE RETURNED AC ADAPTER WAS CONFIRMED TO BE WITHIN SPECIFICATIONS AND DID NOT CONTRIBUTE TO LOW SUCTION. NO EVIDENCE OF ALLEGATION OR MALFUNCTION WAS FOUND.

    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 (B)(6) 2014 TO REPORT THE PURELY YOURS BREAST PUMP SHE USES IS SOUNDING DIFFERENT AS THOUGH IT IS LOSING ENERGY AND THE SUCTION AND SPEED DIALS ARE NOT RESPONDING TO HER CHANGING THE SETTINGS. CUSTOMER STATES THE MILK OUTPUT IS DECREASED DURING PUMPING SHE WAS DIAGNOSED WITH RIGHT BREAST MASTITIS BY HER HEALTH CARE PROVIDER ON (B)(6) 2014. CUSTOMER WAS PRESCRIBED A COURSE OF ORAL ANTIBIOTICS WHICH DID NOT RESOLVE THE INFECTION. SHE WAS PRESCRIBED A DIFFERENT ANTIBIOTIC WHICH HELPED RESOLVE THE MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440847 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other