BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAST PUMP

    MDR report key: 3954664 · Received July 18, 2014

    Report

    Report Number
    1419937-2014-00563
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT TUBING WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE TUBING BE RETURNED FOR EVALUATION. THE DEFECTIVE TUBING HAS NOT BEEN RECEIVED AT MEDELA AS OF (B)(4) 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 WAMBACK, 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 C(B)(4)A11-001.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER TUBING ADAPTER IS BROKEN CAUSING A SUCTION ISSUE. THE DOCTOR HAS DIAGNOSED HER WITH A MASTITIS INFECTION AND PRESCRIBED HER ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422116 FREESTYLE BREAST PUMP HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1