BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP BACKPACK

    MDR report key: 1880476 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00021
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND EVALUATED. THE GEAR BOX WAS FOUND TO BE CRACKED. WHILE THE DEVICE WAS NOT TO SPECIFICATION, NO DEFINITIVE CONCLUSION REGARDING THE 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 STARTED USING HER FIVE MONTH OLD PUMP TWO WEEKS AGO AND DEVELOPED AN INFECTION. THERE WAS CONDENSATION IN THE TUBING AND BACTERIA GREW, AND SHE KEPT USING THE PUMP. CUSTOMER WAS HOSPITALIZED TWICE. CUSTOMER DID NOT CONTACT MEDELA AT THAT TIME. CURRENTLY, SHE IS TAKING MEDICATION AND IS AT HOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R