BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4922022 · Received July 1, 2015

    Report

    Report Number
    3009974348-2015-00084
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 4, 2015
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A REPLACEMENT MOTOR BASE ON 06/04/2015 AND WAS ASKED TO RETURN ORIGINAL MOTOR BASE TO AMEDA, INC. FOR EVALUATION. A (B)(6) PREPAID RETURN LABEL WAS PROVIDED FOR PRODUCT RETURN. 3 PHONE CALLS WERE MADE TO THE CUSTOMER REQUESTING RETURN OF THE PRODUCT. AS OF THIS DATE, PRODUCT HAS NOT BEEN RETURN TO AMEDA, INC. FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED IF PRODUCT IS RETURNED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON 06/04/2015 TO REPORT THE PURELY YOURS BREAST PUMP SHE HAS BEEN USING FOR THE PAST 2 MONTHS HAS LOW SUCTION AND AS A RESULT SHE EXPERIENCES DECREASED MILK OUTPUT. CUSTOMER STATES HER BREAST ARE NOT DRAINING WELL WHEN USING THE BREAST PUMP. CUSTOMER WAS DIAGNOSED WITH RIGHT BREAST MASTITIS ON (B)(6) 2015 AFTER BEING EXAMINED BY HER HEALTH CARE PROVIDER. A 10 DAY COURSE OF ORAL ANTIBIOTICS WAS PRESCRIBED TO TREAT THE MASTITIS. CUSTOMER STATES SOME OF THE MASTITIS SYMPTOMS HAVE RESOLVED WITHIN 3 DAYS OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429728 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other