BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREESTYLE BREASTPUMP

    MDR report key: 1880467 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00020
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. THE ORIGINAL DEVICE WAS RETURNED 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

    THE CUSTOMER STATES THAT SHE WOULD LIKE TO RETURN THE PUMP, BECAUSE IT GAVE HER MASTITIS AND PROBLEMS. CUSTOMER'S SISTER IS A LACTATION CONSULTANT AND SENT NOTIFICATION TO HER SALES REP REGARDING THE PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other