BEUDAMED
    FDA Adverse Event Other Summary report: N

    OZ TWH 99 DBC2

    MDR report key: 2469313 · Received February 15, 2012

    Report

    Report Number
    1317749-2012-00046
    Event Type
    Other
    Date Received
    February 15, 2012
    Report Date
    January 26, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FKO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. 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)(6) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS (PD) CATHETER. THE CUSTOMER STATES THERE WAS A CASE OF CATHETER MATERIAL INTOLERANCE AND INFECTION OF A FEMALE PT FOLLOWING TREATMENT OF PD SOLUTION THROUGH THE DIALYSIS CATHETER. THE PHYSICIAN STATED THE PT DEVELOPED AN IRRITATED AREA AT THE CATHETER EXIT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OZ TWH 99 DBC2 DIALYSIS CATHETER FKO COVIDIEN 8888411009 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other