BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP SHOULDER BAG

    MDR report key: 1880505 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00011
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 10, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT PROBLEM WHEN ON THE PHONE WITH THE CUSTOMER. CUSTOMER ONLY WANTED TO RETURN THE PRODUCT. THE DEVICE WAS RETURNED TO THE MANUFACTURER. NO EVALUATION WAS PERFORMED; DEVICE WAS SCRAPPED. NO CONCLUSION CAN BE DRAWN. 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

    THE CUSTOMER REPORTED THAT SHE HAS HAD THREE BREAST INFECTIONS. A NURSE HAS INDICATED THAT IT WAS FROM THE BREAST PUMP.

    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