BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4871809 · Received June 9, 2015

    Report

    Report Number
    3009974348-2015-00110
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    November 18, 2013
    Report Date
    November 25, 2015
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REC'D AT AMEDA, INC AND EVALUATED FOR LOW SUCTION. THE ALLEGATION WAS NOT CONFIRMED AND NO EVIDENCE OF MALFUNCTION WAS OBSERVED. PRODUCT MET AMEDA SPECS FOR CYCLE RATE AND ALL VACUUM MEASUREMENTS.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC.'S QUALITY MGMT 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 WHILE USING PURELY YOURS BREAST PUMP. CUSTOMER REPORTS LOWER MILK OUTPUT AND HAS EXPERIENCED RECURRENT BOUTS OF CLOGGED MILK DUCTS. CUSTOMER STATES SHE HAS A HISTORY OF AN OVERSUPPLY OF BREAST MILK. CUSTOMER ALLEGES THE PUMP IS INEFFECTIVE AND THE REASON SHE HAD CLOGGED DUCTS FOLLOWED BY MASTITIS WHICH SHE SOUGHT TREATMENT FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369803 PURELY YOURS ELECTRID BRAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other