BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE HANDS FREE BREAST PUMP

    MDR report key: 3834536 · Received March 19, 2014

    Report

    Report Number
    1419937-2014-00285
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MEDELA, AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE POWER ADAPTER TO BE RETURNED FOR EVALUATION. THE DEFECTIVE POWER ADAPTER 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. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE FREESTYLE DEVICE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRANSFORMER HOUSING BROKE AND THE WIRING IS STICKING OUT OF IT, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163467 FREESTYLE HANDS FREE BREAST PUMP HGX MEDELA, AG 67060/9207047

    Patients

    Seq Age Sex Outcome Treatment
    1