BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3121776 · Received May 14, 2013

    Report

    Report Number
    1419937-2013-00258
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ADVISED OF PLACES TO PURCHASE DIFFERENT SIZE BREAST SHIELDS BY THE CUSTOMER SERVICE REPRESENTATIVE. CUSTOMER STATED SHE WOULD SPEAK TO A LACTATION CONSULTANT FIRST. IN FOLLOW UP WITH THE CUSTOMER, SHE STATED SHE SPOKE WITH A LACTATION CONSULTANT WHO BELIEVED THE ISSUE WAS DUE TO IMPROPER BREAST SHIELD SIZING. THE CUSTOMER TRIED SMALLER BREAST SHIELDS BUT FELT THE ORIGINAL ONES ARE BETTER. THE CUSTOMER WAS PRESCRIBED FLUCONAZOLE TO TREAT THE MASTITIS. A MEDELA CLINICIAN SPOKE WITH THE CUSTOMER WHO INDICATED THE ISSUE OF MASTITIS HAD BEEN RESOLVED. 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 SHE HAD GOTTEN THRUSH A MONTH AFTER USING THE BREAST PUMP. IN FURTHER FOLLOW UP WITH THE CUSTOMER, SHE STATED SHE WAS DIAGNOSED WITH AND TREATED FOR MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213057 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC. 57036/87073 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other