BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4864862 · Received June 23, 2015

    Report

    Report Number
    3009974348-2015-00127
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PURELY YOURS BREAST PUMP WAS SENT TO THE CUSTOMER ON 04/10/2014 WITH INSTRUCTIONS TO SEND THE PURELY YOURS PUMP THAT SHE HAD BEEN USING BACK TO AMEDA FOR INVESTIGATION. A FEDEX RETURN LABEL WAS PROVIDED FOR RETURN SHIPMENT. AS OF THIS DATE, THIS PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC.

    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 TO REPORT UNEVEN SUCTION AND POOR MILK EXPRESSION AT THE LEFT BREAST USING THE PURELY YOURS BREAST PUMP. CUSTOMER REPORTS BREAST ENGORGEMENT OVER 2 WEEKS TIME AND STATES SHE IS NOT SURE IF THE PUMP CONTRIBUTED TO THAT ISSUE. CUSTOMER EXCLUSIVELY PUMPS HER BREAST TO GIVE ONLY BREAST MILK TO HER BABY. CUSTOMER WAS DIAGNOSED WITH UNILATERAL LEFT BREAST MASTITIS ON (B)(6) 2014 AND IS GOING TO BE PRESCRIBED ANTIBIOTICS TODAY BY HER HEALTH CARE PROVIDER. SHE BEGAN HAVING MASTITIS SYMPTOMS 2 DAYS PRIOR TO THIS DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406355 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other