BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP STARTER

    MDR report key: 4223256 · Received October 27, 2014

    Report

    Report Number
    1419937-2014-00811
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT BREAST PUMP WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE BREAST PUMP BE RETURNED FOR EVALUATION. THE DEFECTIVE BREAST PUMP HAS NOT BEEN RECEIVED AT MEDELA AS OF 10/23/2014. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. CUSTOMER FOLLOW UP WAS NOT SUCCESSFUL. 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. "MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION, WITH FEW 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, 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 REPORTED TO MEDELA CUSTOMER SERVICE THAT HER PUMP IN STYLE BREAST PUMP HAS LOW SUCTION. SHE ALSO STATED HER DOCTOR HAD DIAGNOSED HER WITH A MASTITIS INFECTION AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681074 PUMP IN STYLE ADVANCED BREASTPUMP STARTER HGX MEDELA, INC. 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other