BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4921994 · Received July 7, 2015

    Report

    Report Number
    3009974348-2015-00139
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    May 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    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. TO REPORT UNEVEN, LOWER SUCTION WHILE USING THE PURELY YOURS BREAST PUMP. THIS ISSUE RESULTED IN DECREASED MILK OUTPUT. CUSTOMER USES THIS BREAST PUMP EXCLUSIVELY BUT REPORTS THE PUMP DOES NOT EFFECTIVELY DRAIN HER BREASTS. CUSTOMER WAS DIAGNOSED WITH LEFT BREAST MASTITIS ON (B)(6) 2014 BY HER HEALTH CARE PROVIDER AND PRESCRIBED ORAL ANTIBIOTICS TO RESOLVE INFECTION. CUSTOMER STATES THE INFECTION IS RESOLVED WITHIN 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440854 PURELY YOURS ELECTRID BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other