BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4921990 · Received June 30, 2015

    Report

    Report Number
    3009974348-2015-00120
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    August 10, 2014
    Report Date
    August 12, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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 08/12/2014 TO REPORT THE PURELY YOURS BREAST PUMP SHE USES GRADUALLY BEGAN EXPERIENCING LOW SUCTION WHICH RESULTED IN DECREASED MILK OUTPUT FROM BREASTS, ESPECIALLY THE RIGHT BREAST WHICH IS THE MAIN MILK PRODUCER. CUSTOMER STATES SHE WAS DIAGNOSED WITH RIGHT BREAST MASTITIS ON (B)(6) 2014 AFTER GOING TO AN URGENT CARE CENTER WITH SYMPTOMS OF A BREAST INFECTION. CUSTOMER WAS PROVIDED WITH A 10 DAY COURSE OF ORAL ANTIBIOTICS WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424080 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other