BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED SHOULDER BAG

    MDR report key: 1880489 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00013
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    January 29, 2010
    Report Date
    January 29, 2010
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. 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 REPORTS SHE HAS HAD CONTINUOUS INFECTIONS AND WAS TOLD BY A LACTATION CONSULTANT THAT HER PUMP MUST BE INFECTED. THE CUSTOMER HAS CLEANED HER PUMP AND REPLACED ALL ACCESSORIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other