BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 1880490 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00007
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 8, 2010
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED 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. THE PRODUCT WAS SCRAPPED AFTER EVALUATION. 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 PUMP WAS PURCHASED ON (B)(6) 2010. THE CUSTOMER USED THE SOFTFIT BREASTSHIELDS WITH THE PUMP. CUSTOMER REPORTED SHE SUSTAINED CUTS AROUND HER AREOLA AFTER USING THE PRODUCT FOR 5 DAYS. CUSTOMER ALSO NOTED A DECREASE IN MILK PRODUCTION. LARGER SIZED BREASTSHIELDS WERE SENT, BUT THE CUSTOMER REPORTED SHE WAS CONTINUING TO GET CUTS. THE CUSTOMER WENT TO HER LACTATION CONSULTANT ON JUNE 30TH. THE LACTATION CONSULTANT STATED SHE HAS NEVER SEEN THIS BEFORE AND INSTRUCTED THE CUSTOMER TO CALL THE MANUFACTURER. THE CUSTOMER HAD BEEN ABLE TO PUMP WITH THE SYMPHONY PUMP PRIOR TO THE FREESTYLE PUMP WITH NO PROBLEM AT ALL.

    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