BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE

    MDR report key: 1880474 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00004
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERIES OF QUESTIONS HAVE BEEN SENT TO THE CUSTOMER IN AN ATTEMPT TO DETERMINE IF THERE IS A PRODUCT ISSUE OR USER INTERFACE ISSUE. A SUPPLEMENTAL REPORT WILL BE FILED UPON RECEIPT OF THE CUSTOMER'S RESPONSES AND COMPLETION OF THE INVESTIGATION, OR IF ATTEMPTS TO OBTAIN THE INFORMATION ARE UNSUCCESSFUL. 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 REPORTS SHE BEGAN USING THE PUMP WITH HER SECOND CHILD. SHE HAD STOPPED USING THE PUMP WITH HER FIRST CHILD BECAUSE AT 7 MONTHS, THE PUMP STARTED CUTTING UP HER NIPPLES (BLEEDING ALL OVER). THE FIRST TIME SHE USED THE PUMP AFTER 2 PLUS YEARS, IT DID IT AGAIN. CUSTOMER REPORTS SHE IS "ALL CUT UP AND BLOODY." THE BREASTSHIELDS ARE SIZE 36 MM, THE BIGGEST SHE COULD FIND. CUSTOMER HAS USED LANOLIN TO TRY TO "GREASE" THE NIPPLE, BUT IT DIDN'T HELP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other