BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG

    MDR report key: 3477105 · Received November 5, 2013

    Report

    Report Number
    1419937-2013-00603
    Event Type
    Injury
    Date Received
    November 5, 2013
    Date of Event
    September 30, 2013
    Report Date
    November 4, 2013
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A COURTESY 30 MM BREAST SHIELDS AND ADVISED THAT SHE BE PROPERLY FITTED BY A LACTATION CONSULTANT. ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER TO GET ADDITIONAL COMPLAINT INFORMATION WERE UNSUCCESSFUL. SHOULD ADDITIONAL INFORMATION, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. ON (B)(6) 2013, A MEDELA CLINICIAN SPOKE WITH THE CUSTOMER AND SHE REPORTED THAT SHE HAS RECEIVED REPLACEMENT BREAST SHIELDS SENT BY CS. SHE HAS ALSO GOTTEN HELP FROM HOSPITAL LC WHERE CUSTOMER WORKS AS AN RN. LC FOUND SHE HAS A YEAST INFECTION AND HER BABY HAS THRUSH. BOTH ARE BEING TREATED WITH PRESCRIPTION MEDICATIONS AND TOPICAL GENTIAN VIOLET. CUSTOMER FEELS THE SITUATION IS IMPROVING. SHE STEAM-STERILIZES PUMP PARTS AFTER EACH USE AND STERILIZES THEM IN BOILING WATER EACH EVENING, WHICH IS IMPORTANT TO PREVENT REOCCURRENCE OF YEAST INFECTION. THIS ISSUE IS RESOLVING TO CUSTOMER'S SATISFACTION AND FURTHER CLINICAL FOLLOW-UP IS NOT INDICATED. CUSTOMERS USING 27 MM BREAST SHIELDS ((B)(4)) REPORTING A BREAST SHIELD SIZING ISSUE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PAIN AND DISCOMFORT WHILE PUMPING. MEDELA CUSTOMER SERVICE WENT OVER CORRECT SIZING AND ADVISED TO SEE A LACTATION CONSULTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569784 PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG HGX MEDELA INC. 57027/8107176 (87274)

    Patients

    Seq Age Sex Outcome Treatment
    1