BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4864847 · Received June 23, 2015

    Report

    Report Number
    3009974348-2015-00126
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    April 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 ON (B)(6) 2014 TO REPORT THE PURELY YOURS BREAST PUMP SHE EXCLUSIVELY USES TO EXPRESS HER BREAST MILK HAS VERY LOW SUCTION AND IT NEVER FULLY DRAINS HER BREASTS OF MILK. CUSTOMER REPORTS DECREASE MILK OUTPUT AND SUBSEQUENT UNILATERAL RIGHT BREAST MASTITIS ON (B)(6) 2014. CUSTOMER CONTACTED HER HEALTH CARE PROVIDER AND WAS PRESCRIBED A 10 DAY COURSE OF ORAL ANTIBIOTICS TO RESOLVE MASTITIS. SHE BEGAN USING A MANUAL BREAST PUMP TO FULLY DRAIN HER BREASTS. MASTITIS RESOLVED WITHIN 1-2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406331 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other