BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDELA PUMP IN STYLE ADVANCED BREAST PUMP

    MDR report key: 1914340 · Received November 16, 2010

    Report

    Report Number
    1419937-2010-00044
    Event Type
    Other
    Date Received
    November 16, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFO AND THE ORIGINAL PUMP HAVE BEEN UNSUCCESSFUL. AS NO FURTHER INFO WAS PROVIDED AND THE ORIGINAL PRODUCT HAS NOT BEEN RETURNED FOR FURTHER EVAL, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE CAN BE DETERMINED. SHOULD NEW INFO OR THE PRODUCT BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED AT THAT TIME. 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, THE PUMP WAS NOT WORKING PROPERLY (LOW SUCTION). CUSTOMER REPORTED DEVELOPING AN INFECTION AND HAD TO STOP BREAST FEEDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other