BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAT PUMP

    MDR report key: 3950974 · Received July 14, 2014

    Report

    Report Number
    1419937-2014-00555
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDELA, AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER. FOLLOW UP ATTEMPTS WITH THE CUSTOMER TO GET ADDITIONAL COMPLAINT INFORMATION ARE ON-GOING. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED OR CORRECT INFORMATION A FOLLOW UP REPORT WILL BE FILED. 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 CUSTOMER SERVICE THAT PUMP HAD LOW/NO SUCTION AND AS A RESULT SHE GOT MASTITIS AND WAS TREATED WITH ANTIBIOTICS BY HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410101 FREESTYLE BREAT PUMP HGX MEDELA, AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1