BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP SHOULDER BAG

    MDR report key: 1880484 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00026
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    August 31, 2009
    Report Date
    August 31, 2009
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW PUMP WAS SENT TO THE CUSTOMER. A MANUFACTURER REPRESENTATIVE SPOKE WITH THE CUSTOMER AND SUGGESTED THAT SHE TAKE THE NEW PUMP WITH THE NEW BREASTSHIELDS TO THE LACTATION CONSULTANT TO MAKE SURE THE SIZE IS THE CORRECT FIT. THE CUSTOMER RETURNED THE ORIGINAL DEVICE FOR EVALUATION/INVESTIGATION. THE DEVICE WAS RECEIVED AND SCRAPPED; NO INVESTIGATION RECORDS HAVE BEEN LOCATED. NO DEFINITIVE CONCLUSION AS TO THE CAUSE OF THE EVENT CAN BE MADE. 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 STATES SHE IS EXCLUSIVELY PUMPING USING THE 24MM BREASTSHIELD. WHEN PUMPING, A GOOD AMOUNT OF THE AREOLA IS IN THE TUNNEL, CAUSING IT TO RUB AND BE PAINFUL. CUSTOMER IS USING THE PUMP AT THE LOWEST LEVEL AND FEELS THAT THE SUCTION IS TOO STRONG. THE NIPPLE STARTS TO TURN DARK PURPLE/ALMOST BLACK WHEN PUMPING, AND WHEN COMPLETE, THE TIP OF THE NIPPLE IS PINK AND VERY TENDER AND PAINFUL. CUSTOMER STATED THAT SHE HAD ONLY SPOKEN WITH A LACTATION CONSULTANT OVER THE PHONE AND THAT SHE HAS NOT BEEN FITTED FOR DIFFERENT SIZE BREASTSHIELDS.

    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