BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2921702 · Received January 15, 2013

    Report

    Report Number
    1419937-2013-00035
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    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 THE F/U WITH THE CUSTOMER ON (B)(6) 2012 SHE STATED THAT HER OB HAD DIAGNOSED HER WITH MASTITIS THAT STARTED ON (B)(6) 2013. SHE WAS PRESCRIBED AN ANTIBIOTIC FOR IT BUT WAS UNSURE OF THE NAME. SHE DID SEE A LACTATION CONSULTANT TO GET FITTING FOR BREASTSHIELDS AND DID GET A BIGGER SIZE SHIELD. THE CUSTOMER STATED THAT THE PUMP SEEMED TO BE WORKING FINE THEREFORE, A NEW PUMP WAS NOT SHIPPED OUT. A MEDELA CLINICIAN SPOKE TO THE CUSTOMER ON (B)(6) 2013, AT WHICH TIME THE CUSTOMER CONFIRMED THAT HER ISSUE WAS RESOLVED WITH MEDICATION THAT CLEARED THE INFECTION, AND NEW LARGER BREASTSHIELDS. MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION, WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT. THE RISK OF MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PRECIOUSLY, ESPECIALLY THOSE WITH A HISTORY OF MASTITIS. "BREASTFEEDING AND HUMAN LACTATION" (RIORDANA AND WAMBACH, 4TH EDITION, PAGE 294). IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCOMFORT/SORENESS WHEN PUMPING, CUSTOMER REPORTS SORE/BLEEDING NIPPLES, MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21758 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063

    Patients

    Seq Age Sex Outcome Treatment
    1