BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAST PUMP

    MDR report key: 3131121 · Received May 23, 2013

    Report

    Report Number
    1419937-2013-00273
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 21, 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

    CUSTOMER WAS REFERRED TO BNN/OTHER ORDERING SOURCE AS THE PRODUCT WAS OUT OF WARRANTY. CUSTOMER CURRENTLY IS USING A NON-MEDELA BREAST PUMP WITH HER SECOND CHILD. IN THE FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2013, SHE INDICATED THE FREESTYLE BREAST PUMP WORKED GREAT FOR FIRST 4 MONTHS; ((B)(6) 2011) AND THEN STARTED HAVING LOW SUCTION ISSUES. SIX WEEKS LATER ((B)(6) 2011) CUSTOMER WAS DIAGNOSED AND TREATED FOR MASTITIS AND WAS PRESCRIBED THE ANTIBIOTIC DICLOXACILLIN. THE MASTITIS HAD CLEARED UP WITH NO REOCCURRENCES. "MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION, WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT. THE RISK OF MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OF MASTITIS." [BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, PAGE 294)]. MEDELA ACKNOWLEDGES THAT THIS REPORT IS BEING SUBMITTED LATE. 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. 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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER PUMP HAS LOW SUCTION AND ENDED UP ENGORGED WITH MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229781 FREESTYLE BREAST PUMP HGX MEDELA, INC. 67060

    Patients

    Seq Age Sex Outcome Treatment
    1