BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-Z COIL SPECIAL (OZ C CA2)

    MDR report key: 1574129 · Received December 16, 2009

    Report

    Report Number
    1317749-2009-00278
    Event Type
    Malfunction
    Date Received
    December 16, 2009
    Report Date
    November 23, 2009
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    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)(6) 2009 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE PATIENT SUFFERED FROM PERITONITIS. THE CATHETER HAS BEEN EXPLANTED AND REPLACED BY A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-Z COIL SPECIAL (OZ C CA2) PERITONEAL DIALYSIS CATHETER FJS COVIDIEN 8888425710 8888425710

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK