BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4844306 · Received June 2, 2015

    Report

    Report Number
    3009974348-2015-00086
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    November 15, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC. AN EXPEDIATED PRE-PAID (B)(4) LABEL WAS SENT TO THE CUSTOMER IN AN EFFORT TO OBTAIN THE PRODUCT FOR EVALUATION. 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 LOW SUCTION AND DECREASED MILK OUTPUT WHILE USING THE PURELY YOURS BREAST PUMP SINCE (B)(6) 2013. CUSTOMER DESCRIBES SYMPTOMS OF LEFT BREAST UNILATERAL MASTITIS THAT BEGAN ON (B)(6) 2013. CUSTOMER CONTACTED HER HEALTH CARE PROVIDER ON (B)(6) 2013 AND A TELEPHONE ASSESSMENT OF MASTITIS WAS MADE BY THE RN. CUSTOMER ELECTED NOT TO HAVE THE PRESCRIPTION FOR ANTIBIOTICS FILLED BUT RELIED ON NATURAL HEALING TECHNIQUES TO RESOLVE THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357263 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other