BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED STARTER

    MDR report key: 5033140 · Received August 26, 2015

    Report

    Report Number
    1419937-2015-00253
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 25, 2015
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A LARGER SIZE BREASTSHIELD TO RESOLVE THE ISSUE OF PAIN AND IT WAS REQUESTED THAT THE CUSTOMER'S BREASTSHIELD BE RETURNED FOR EVALUATION. 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). SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE WAS HAVING DIFFICULTY PUMPING AND WAS EXPERIENCING PAIN WHILE USING HER PUMP IN STYLE ADVANCED BREAST PUMP DUE TO THE WRONG SIZE BREASTSHIELD. THE CUSTOMER ALSO STATED THAT SHE WAS DIAGNOSED WITH THRUSH AND WAS PRESCRIBED AN ANTIBIOTIC BY HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565323 PUMP IN STYLE ADVANCED STARTER HGX HGX MEDELA INC. 8107084 (87073)/57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other