BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4844321 · Received June 2, 2015

    Report

    Report Number
    3009974348-2015-00090
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    November 18, 2013
    Report Date
    November 18, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC. FOR EVALUATION AS OF THIS DATE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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) 2013 TO REPORT USING THE PURELY YOURS BREAST PUMP ONCE PER DAY. CUSTOMER REPORTS THE PUMP'S CYCLING SLOWS DURING PUMPING AND BREAST MILK FLOWS BACK UP INTO THE DIAPHRAGM AREA. CUSTOMER STATES SHE CONTACTED HER HEALTH CARE PROVIDER ON (B)(6) 2013 FOR BREAST PAIN AND SYMPTOMS OF A BREAST INFECTION. SHE WAS DIAGNOSED WITH UNILATERAL MASTITIS AND WAS PRESCRIBED ORAL ANTIBIOTICS TO TREAT THE INFECTION. CUSTOMER REPORTS FEELING MUCH BETTER AFTER STARTING THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357195 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other