BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN NECK COIL CATH CA2 LEFT

    MDR report key: 2753788 · Received September 14, 2012

    Report

    Report Number
    1317749-2012-00208
    Event Type
    Other
    Date Received
    September 14, 2012
    Report Date
    August 15, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 09/14/2012. 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 CATHETER. THE CUSTOMER STATES THE PERITONEAL CATHETER WAS IMPLANTED ON (B)(6) 2012. THE CATHETER MIGRATED TO THE FLANK IN THE TRUNK OF THE UTERUS. A LAPAROSCOPIC PROCEDURE WAS COMPLETED ON (B)(6) 2012 TO CORRECT THE LOCATION OF THE MIGRATED CATHETER. THE CATHETER MIGRATED ONCE MORE BUT CAUSED NO DIFFICULTY TO THE PATIENT. PERITONEAL DIALYSIS TREATMENT HAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN NECK COIL CATH CA2 LEFT PD CATHETER FJS COVIDIEN 8888413807 934515

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other