BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE

    MDR report key: 1880504 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00018
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER (B)(4) WERE UNSUCCESSFUL. THE CUSTOMER RETURNED THE PUMP FOR EVALUATION/ INVESTIGATION. VACUUM AND CYCLES PER MINUTE TESTS WERE CONDUCTED; THE DEVICE PERFORMED TO SPECIFICATIONS. NO DEFINITIVE CAUSE OF THE REPORTED EVENT CAN BE DETERMINED. AS PART OF COMPLAINT REMEDIATION ACTIVITIES, HISTORICAL COMPLAINT RECORDS ARE BEING REVIEWED FOR POSSIBLE ADVERSE EVENTS. MEDELA IS COMMITTED TO CREATING AN EFFECTIVE COMPLAINT HANDLING PROCESS TO ASSURE COMPLAINTS ARE PROCESSED IN A TIMELY MANNER AND EVALUATED FOR PART 803 REPORTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE PUMP SUCTION IS TOO HIGH AND WILL NOT TURN DOWN. CUSTOMER STATED THIS HAS BECOME PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE PUMP, BREAST, POWERED HGX MEDELA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other