BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREESTYLE HANDS-FREE BREAST PUMP

    MDR report key: 1943499 · Received October 25, 2010

    Report

    Report Number
    1419937-2010-00036
    Event Type
    Other
    Date Received
    October 25, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITIONAL FOLLOW-UP, THE CUSTOMER STATED HER DOCTOR RECOMMENDED SHE USE A HOSPITAL-GRADE PUMP. SHE INDICATED SHE HAD AN INFECTION (WAS GETTING BLOCKED DUCTS AND MASTITIS), WHICH IS WHY SHE WENT TO SEE HER DOCTOR AND HE MADE THE RECOMMENDATION FOR THE NEW PUMP. THE CUSTOMER DID NOT BELIEVE IT AS A DEFECT IN THE PUMP, ONLY POSSIBLY IN THE SHIELD (BECAME WARPED). THE CUSTOMER STAYED WITH THE SAME MEDELA PUMP, BUT SWITCHED TO LARGER BREAST SHIELDS. SHE HAD NO ISSUES SINCE. THE ORIGINAL PRODUCTS WERE NOT RETURNED FOR EVALUATION/ INVESTIGATION. THEREFORE, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SHE WAS EXPERIENCING PAIN FROM HER BREAST SHIELDS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other