BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4871821 · Received June 17, 2015

    Report

    Report Number
    3009974348-2015-00124
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    March 21, 2014
    Report Date
    March 24, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 SPECS 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 MGMT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACT AMEDA, INC. TO REPORT THE PURELY YOURS BREAST PUMP SHE USES WHEN AT WORK BEGAN CYCLING DIFFERENTLY; SUCTION WAS LOWER AND THE PUMP SOUNDED DIFFERENT DURING ITS CYCLING PROCESS. MILK OUTPUT WAS DECREASED DUE TO THESE ISSUES. CUSTOMER REPORTS A UNILATERAL MASTITIS WAS DIAGNOSED ON (B)(6) 2014. CUSTOMER PHONE HER HEALTH CARE PROVIDER AND WAS PRESCRIBED A 10 DAY COURSE OF ORAL ANTIBIOTICS WHICH RESOLVED THE MASTITIS SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392989 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other