BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP SHOULDER BAG

    MDR report key: 1880486 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00002
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO MEDELA FOR EVALUATION/ INVESTIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED PAST THE INITIAL COMPLAINT REPORT; THEREFORE, NO CONCLUSION CAN BE DRAWN AS TO THE DEFINITIVE CAUSE OF THE EVENT. THE CUSTOMER WAS ADVISED AT THE TIME OF THE INITIAL CALL THAT SHE MAY BE IN BETWEEN SIZES FOR THE BREAST SHIELDS. 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 CALLED STATING SHE HAS HAD BLISTERS FROM PUMPING. SHE WAS SENT 21MM BREAST SHIELDS SINCE HER AREOLA IS PULLED INTO THE TUNNEL. THE CUSTOMER NOW REPORTS HER NIPPLES ARE CRACKED AND CHAFFED AND BLEEDING. SHE IS GOING TO SEE A LACTATION CONSULTANT TO GET HELP WITH THIS ISSUE.

    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