BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREESTYLE HANDS FREE BREASTPUMP

    MDR report key: 1880480 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00016
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE PUMP FOR EVALUATION/INVESTIGATION. TESTS SHOWED IT WAS NOT RELEASING THE VACUUM (OUT OF SPECIFICATION). WHILE THE DEVICE DID NOT TEST TO SPECIFICATIONS, NO DEFINITIVE CONCLUSION REGARDING THE CAUSE OF THE REPORTED EVENT CAN BE DETERMINED. PRODUCT HAS BEEN SCRAPPED. 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 THAT THE PUMP IS PUMPING TOO HARD FOR HER ON DOUBLE; THAT IT MADE HER BLEED. CUSTOMER BROUGHT THE PUMP TO HER LACTATION CONSULTANT FOR TESTING THE SUCTION AND THE RESULTS INDICATED THAT THE SUCTION WAS "WAY TOO HIGH."

    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