BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4922032 · Received July 9, 2015

    Report

    Report Number
    3009974348-2015-00142
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 29, 2014
    Report Date
    June 30, 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
    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 BOTH 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 AMENDA, INC. ON (B)(6) 2014 TO REPORT THE PURELY YOURS BREAST PUMP SHE USES AT HOME IN THE EVENING AND NIGHT HAS LOW SUCTION AND THEREFORE DECREASED MILK OUTPUT. CUSTOMER USES A HOSPITAL GRADE BREAST PUMP DURING THE DAY WHEN SHE VISITS HER PRETERM INFANT IN THE NICU; THIS PUMP DRAINS HER BREASTS WELL. CUSTOMER REPORTS CONTACTING HER HEALTH CARE PROVIDER ON (B)(6) 2014 FOR SYMPTOMS OF UNILATERAL MASTITIS. SHE WAS PRESCRIBED ORAL ANTIBIOTICS THAT HAVE RESOLVED THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447769 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other