BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAST PUMP

    MDR report key: 3149243 · Received June 4, 2013

    Report

    Report Number
    1419937-2013-00301
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER AGREED TO RETURN THE PRODUCT FOR TESTING AND INDICATED THAT SHE HAS ALREADY SHIPPED THE PRODUCT BACK, THOUGHT IT HAS NOT YET BEEN RECEIVED BY MEDELA, INC FOR TESTING/ANALYSIS. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT SHE STARTED OUT WITH CLOGGED DUCTS THAT EVENTUALLY LEAD TO MASTITIS. CUSTOMER STATED SHE WAS NURSING EXCLUSIVELY AND DID NOT WANT TO TAKE AN ANTIBIOTIC TO TREAT THE MASTITIS. CUSTOMER STATED THAT WITH THE USE OF A RENTAL PUMP, THE ISSUE IS RESOLVED. A MEDELA CLINICIAN SPOKE TO THE CUSTOMER ON (B)(6) 2013, AT WHICH TIME THE CUSTOMER CONFIRMED THAT HER ISSUES WERE RESOLVED WITH THE USE OF THE RENTAL PUMP, AND EVEN THOUGH THE CLOGGED DUCTS HAVE RECURRED, IT HAS NOT PROGRESSED TO MASTITIS AGAIN. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. REPORTED ISSUES OF MASTITIS ARE UNDER INVESTIGATION IN (B)(4). SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT WHILE USING THE BREAST PUMP, SHE EXPERIENCED MASTITIS AND CLOGGED MILK DUCTS FREQUENTLY. IT WAS NOT CLEAR THAT CUSTOMER HAD MASTITIS AT THE TIME OF THE COMPLAINT REPORT. A CLINICIAN SPOKE WITH THE CUSTOMER ON (B)(6) 2013 AND CONFIRMED THAT THE CUSTOMER WAS DIAGNOSED WITH AND TREATED FOR MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246092 FREESTYLE BREAST PUMP HGX MEDELA, INC. 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other