BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HGX

    MDR report key: 3779265 · Received April 21, 2014

    Report

    Report Number
    1419937-2014-00366
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDELA CUSTOMER SERVICE REP REQUESTED THE CUSTOMER TO CALL US DIRECTLY TO TROUBLESHOOT AND/OR REPLACE THE BREAST PUMP AS NEEDED. THE CUSTOMER HAS NOT CONTACTED MEDELA CUSTOMER SERVICE AS OF (B)(4) 2015. THE PRODUCT INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED FOR EVALUATION AT THIS TIME. 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 FOR CONSEQUENCES FOR SUCKLING INFANT. THE RISK OF 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, PG 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 REPORTED THAT HER BREAST PUMP HAS LOW SUCTION AND MOTOR IS LOUD. SHE ALSO HAS HAD MASTITIS INFECTIONS IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241927 HGX PUMP IN STYLE HGX MEDELA, INC. 57XXXX

    Patients

    Seq Age Sex Outcome Treatment
    1