BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP SHOULDER BAG

    MDR report key: 1880485 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00024
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    February 3, 2009
    Report Date
    February 3, 2009
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE PUMP FOR EVALUATION/ INVESTIGATION. VACUUM AND CYCLE PERFORMANCE TESTS WERE CONDUCTED; THE DEVICE OPERATED TO SPECIFICATIONS. NO DEFINITIVE CONCLUSION FOR THE CAUSE OF THE 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 PURCHASED THE PUMP (B)(6) 2009. CUSTOMER IS EXPERIENCING PAIN. SHE WENT TO SEE THE LACTATION CONSULTANT, WHO DID ALL THE TROUBLESHOOTING, AND BELIEVES THAT THE MOTOR JUST ISN'T RUNNING CORRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other