BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP STARTER

    MDR report key: 3883560 · Received June 9, 2014

    Report

    Report Number
    1419937-2014-00478
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. ATTEMPTS TO GET ADDITIONAL COMPLAINT INFO ARE ONGOING. SHOULD ADDITIONAL INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. THE ISSUE WITH YEAST INFECTION/THRUSH POTENTIALLY FROM USING THE PUMP IN STYLE PUMP IS CURRENTLY UNDER INVESTIGATION IN (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT HER SUCTION IS HIGH ON HER PUMP IN STYLE AND SHE HAD DEVELOPED THRUSH AND IS REPORTING PAIN WHEN USING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333998 PUMP IN STYLE ADVANCED BREASTPUMP STARTER HGX MEDELA, INC. 57081

    Patients

    Seq Age Sex Outcome Treatment
    1