BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP

    MDR report key: 3213832 · Received July 3, 2013

    Report

    Report Number
    1419937-2013-00349
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ADVISED A MEDELA CLINICIAN THAT SHE IS USING LARGER BREAST SHIELDS WITH COMFORT, BUT "HAS DIFFICULTY EMPTYING HER BREASTS AND USES MANUAL EXPRESSION AFTER PUMPING." THE CUSTOMER WAS ADVISED TO ALTERNATE BETWEEN STIMULATION AND EXPRESSION PHASES OF HER PUMP TO EFFECT BETTER BREAST EMPTYING. 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 BIGGER BREAST SHIELDS AND A FULL COURSE OF ANTIBIOTICS RECEIVED BY HER DOCTOR. THE CUSTOMER IS NOT RETURNING THE PUMP FOR EVAL AS SHE IS STILL USING THE PRODUCT. IT CANNOT BE DEFINITELY 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 BREASTS WERE NOT EMPTYING AS THEY NORMALLY DO, AND SHE DEVELOPED MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304007 PUMP IN STYLE ADVANCED BREAST PUMP HGX MEDELA, INC. 57036 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other