BEUDAMED
    FDA Adverse Event Injury Summary report: N

    67060 FREESTYLE HANDS FREE

    MDR report key: 3842690 · Received May 19, 2014

    Report

    Report Number
    1419937-2014-00416
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDELA CUSTOMER SERVICE WAS UNABLE TO TROUBLESHOOT THE DEVICE DUE TO THE CUSTOMER BEING PREGNANT BUT REQUESTED TO CALL BACK AND TROUBLESHOOT ONCE SHE STARTS USING THE BREAST PUMP AGAIN. THE CUSTOMER STATED THAT THE PUMP WAS ABLE TO EXPRESS MILK AND EMPTY HER BREASTS WHEN SHE USED IT FOR HER FIRST CHILD. THE CUSTOMER REFUSED TO SEND THE PUMP IN FOR A PRODUCT EVALUATION AT THIS TIME. 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 F/U WAS NOT SUCCESSFUL. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE REC'D, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME. 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 THAT WHEN SHE USED THE PUMP 18 MONTHS AGO SHE HAD SEVEN OCCURRENCES OF A MASTITIS INFECTION WHILE USING THE BREAST PUMP. THE DOCTOR DIAGNOSED HER WITH A MASTITIS INFECTION AND PRESCRIBED HER ANTIBIOTICS. THE CUSTOMER REPORTED THAT HER DOCTOR TOLD HER THAT THERE WAS BACTERIA IN HER PUMP AND THAT IS WHY SHE GOT THE MASTITIS INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295070 67060 FREESTYLE HANDS FREE HGX MEDELA, INC. 67060

    Patients

    Seq Age Sex Outcome Treatment
    1