BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5006565 · Received August 6, 2015

    Report

    Report Number
    3009974348-2015-00132
    Event Type
    Injury
    Date Received
    August 6, 2015
    Date of Event
    November 7, 2013
    Report Date
    November 12, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS EVALUATED FOR EVIDENCE OF ALLEGATION. THE RETURNED AMEDA PURELY YOURS BREAST PUMP MET AMEDA SPECIFICATIONS FOR 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 (B)(6) 2013 TO REPORT LOW, UNEVEN SUCTION WHILE PUMPING WITH THE PURELY YOURS BREAST PUMP. SHE REPLACED MANY PUMP PIECES WITH NO RESOLUTION. CUSTOMER REPORTS DECREASED MILK OUTPUT AND MOTOR SOUNDS DISTORTED. CUSTOMER'S BREASTS WERE LEFT ENGORGED AND PAINFUL DUE TO INEFFECTIVE MILK DRAINAGE FROM BREASTS. CUSTOMER REPORTS A DIAGNOSIS OF UNILATERAL MASTITIS AFTER CONTACTING HER HEALTH CARE PROVIDER. SHE WAS PRESCRIBED ORAL ANTIBIOTICS, NURSED OFTEN AND TREATED BREAST WITH COLD COMPRESSES THAT RESOLVED HER INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521290 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other