BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2940542 · Received January 30, 2013

    Report

    Report Number
    1419937-2013-00056
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    April 1, 2012
    Report Date
    January 8, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP WITH THE CUSTOMER, SHE STATED THAT IN (B)(6) 2012, SHE WENT FROM USING A SYMPHONY BREAST PUMP TO THE PUMP IN STYLE AND DEVELOPED MASTITIS, FOR WHICH SHE RECEIVED AN ANTIBIOTIC FOR TREATMENT. THE CUSTOMER STATED THAT SHE WAS NOT PUMPING WITH THE PUMP IN STYLE AS OFTEN AS SHE SHOULD HAVE AND THAT IS HOW SHE DEVELOPED MASTITIS. THE CUSTOMER ALSO STATED THAT SINCE SHE HAS HAD MASTITIS, HER BREAST IS SENSITIVE AND SHE GETS BLOOD CLOTS ONCE IN AWHILE. THE CUSTOMER IS STILL CURRENTLY USING THE PUMP. THE PRODUCT INVOLVED IN THE COMPLAINT IS NOT BEING RETURNED FOR EVALUATION/INVESTIGATION. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. 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 A BLOOD CLOT GOT LODGED IN THE VALVE AND CONNECTOR FOR HER BREAST PUMP. AS A RESULT, BLOOD ENTERED THE TUBING AND SHE CALLED TO INQUIRE ABOUT INSTRUCTIONS FOR CLEANING THE TUBING. THE CUSTOMER STATED THAT THE PUMP WORKS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41430 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1