BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3883578 · Received June 9, 2014

    Report

    Report Number
    1419937-2014-00486
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDELA CUSTOMER SERVICE SENT 21 MM BREAST SHIELDS TO THE CUSTOMER AND RECOMMENDED HER TO GET FITTED BY A LACTATION CONSULTANT. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/ INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. CUSTOMER FOLLOW UP WAS NOT SUCCESSFUL. 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. "MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION, WITH FEW CONSEQUENCES FOR SUCKLING INFANT. THE RISK MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OF MASTITIS". [BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, PAGE 294)]. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. REPORTED ISSUES OF MASTITIS ARE UNDER INVESTIGATION IN (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED SHE IS GETTING LOWER MILK EXPRESSION AND HER DOCTOR HAS DIAGNOSED HER WITH A MASTITIS INFECTION AND TREATED HER WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334000 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063

    Patients

    Seq Age Sex Outcome Treatment
    1