BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR KIT

    MDR report key: 1317033 · Received January 9, 2009

    Report

    Report Number
    2518902-2009-00053
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    November 21, 2008
    Report Date
    January 9, 2009
    Manufacturer
    MEDCOMP
    Product Code
    NFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDCOMP IS WAITING FOR THE RETURN OF THE SAMPLE AND ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE TO DATE NEITHER HAS BEEN RECEIVED. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPAIR KIT CAME APART FROM THE CATHETER WHILE THE PATIENT WAS ON DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR KIT REPAIR KIT NFK MEDCOMP RPK-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention