BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 1880501 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00017
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    March 30, 2010
    Report Date
    March 30, 2010
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPRESENTATIVE WENT THROUGH TROUBLESHOOTING WITH CUSTOMER; NO ISSUES WERE FOUND. EVEN THOUGH TROUBLESHOOTING REVEALED THAT THE PUMP APPEARED TO BE WORKING FINE, A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. ADDITIONAL FOLLOW-UP WITH THE CUSTOMER ON (B)(6) 2010, CONFIRMED THAT THE CUSTOMER HAS HAD NO FURTHER ISSUES AND THAT SHE HAD RECOVERED FULLY. THE PUMP WAS RETURNED FOR EVALUATION/INVESTIGATION. VACUUM AND CYCLE TESTS WERE CONDUCTED; RESULTS INDICATE THAT THE DEVICE PERFORMED TO SPECIFICATIONS. NO DEFINITIVE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE REPORTED EVENT. 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 ORIGINALLY BEGAN PUMPING, WITH NO INCIDENT, IN (B)(6) 2009 USING HER SISTER'S PUMP. THEN, IN (B)(6) 2010 SHE PURCHASED HER OWN PUMP. CUSTOMER REPORTS HAVING PAIN AND EXPERIENCING BLEEDING OUT OF ONE OF BOTH NIPPLES FROM THE BEGINNING OF USE. AT TIMES SHE WOULD ONLY PUMP OUT BLOOD. CUSTOMER SPOKE WITH A DOCTOR, A BREST SPECIALIST, AND A LACTATION CONSULTANT. ALL SAY THERE IS NOTHING MEDICALLY WRONG WITH HER BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE HANDS-FREE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other