BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2940540 · Received January 30, 2013

    Report

    Report Number
    1419937-2013-00059
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 2, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE WAS EXPERIENCING PAIN ON ONE SIDE WHILE USING THE 24MM BREAST SHIELD. CUSTOMER SERVICE PROVIDED THE CUSTOMER WITH A 36MM BREAST SHIELD AND ADVISED THE CUSTOMER TO CONTACT A LACTATION CONSULTANT. A MEDELA CLINICIAN SPOKE WITH THE CUSTOMER, THE CUSTOMER STATED THAT SHE WAS TREATED BY A PHYSICIAN WHO PRESCRIBED AN ANTIBIOTIC FOR AN INFECTION. THIS WAS NOT TERMED MASTITIS AND SHE DISPLAYED NO CLASSIC MASTITIS SYMPTOMS, JUST LOCALIZED REDNESS ON HER NIPPLES. THE CUSTOMER HAS COMPLETED THE COURSE OF ANTIBIOTICS AND CHANGED TO THE LARGER BREAST SHIELDS, ALL SYMPTOMS HAVE RESOLVED. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S INFECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE HAS PAIN WHILE PUMPING ON ONE SIDE. SHE FEELS THE BREAST SHIELD DOES NOT FIT CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40633 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/87073

    Patients

    Seq Age Sex Outcome Treatment
    1 Other