BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CLOSUREFAST CATHETER

    MDR report key: 3042017 · Received April 2, 2013

    Report

    Report Number
    2953189-2013-00032
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH UNKNOWN CLOSUREFAST CATHETER. THE CUSTOMER STATES THAT A PATIENT HAD THE VENEFIT PROCEDURE APPROX 2 WEEKS AGO. THE PATIENT CAME BACK THROUGH THE EMERGENCY ROOM THIS PAST WEEKEND WITH PAIN IN UPPER THIGH, POSSIBLE MARKINGS OF A SKIN BURN, REDNESS IN A LARGE AREA OF THE THIGH AND A FEVER. THE PHYSICIAN IS CONCERNED THAT THEY MAY HAVE A SKIN BURN BUT IS NOT CERTAIN. UNKNOWN MEDICAL INTERVENTION, HOWEVER, THE PATIENT HAS BEEN HOSPITALIZED SINCE LAST SUNDAY (B)(6) 2013 DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133848 UNKNOWN CLOSUREFAST CATHETER UNKNOWN CLOSUREFAST CATHETER GEI COVIDIEN UNKNOWN CLOSURE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK