BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 1880503 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00015
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    June 5, 2010
    Report Date
    June 5, 2010
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED PUMP FOR EVALUATION/INVESTIGATION. VACUUM LEVELS AND CYCLES PER MINUTE WERE TESTED; ALL WERE WITHIN SPECIFICATIONS. NO DEFINITIVE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE 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 PURCHASED FREESTYLE PUMP AND REPORTED SHE DEVELOPED MASTITIS. THE LACTATION CONSULTANT ALLEGED THAT IT WAS DUE TO THE PUMP.

    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