BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5112436 · Received September 29, 2015

    Report

    Report Number
    3009974348-2015-00176
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS EVALUATED FOR EVIDENCE OF ALLEGATION. 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 THE FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2014 TO REPORT THE PURELY YOURS BREAST PUMP SHE USES TO EXPRESS BREAST MILK FOR HER BABY DOES NOT WORK WELL FOR HER. SHE ALLEGES DEVELOPING A BREAST INFECTION, MASTITIS, WHICH WAS CAUSED BY THIS BREAST PUMP NOT FUNCTIONING PROPERLY. SHE STATES THE PUMP DID NOT DRAIN THE MILK FROM HER BREASTS DUE TO LOW SUCTION RESULTING IN DECREASED MILK OUTPUT. CUSTOMER WAS PRESCRIBED ORAL ANTIBIOTICS BY HER HEALTH CARE PROVIDER WHICH RESOLVED HER INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643287 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other