BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 6041215 · Received October 19, 2016

    Report

    Report Number
    1419937-2016-00266
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 8, 2016
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP WITH A MEDELA CLINICIAN ON (B)(6) 2016, THE CUSTOMER REPORTED THAT SHE HAD THRUSH AND WAS TAKING A 10 DAY COURSE OF DIFLUCAN PRESCRIBED BY HER PHYSICIAN. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S THRUSH. REPORTED ISSUES OF THRUSH ARE UNDER INVESTIGATION IN (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE SUCTION ON HER PUMP IN STYLE ADVANCED GO TOTE WAS TOO HIGH AND CAUSING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691382 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA INC 57063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other