BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE COIL CATHETER

    MDR report key: 103983 · Received June 30, 1997

    Report

    Report Number
    103983
    Event Type
    Injury
    Date Received
    June 30, 1997
    Date of Event
    May 17, 1997
    Report Date
    June 9, 1997
    Manufacturer
    LIFE MED OF CALIFORNIA
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH END-STAGE RENAL DISEASE. SUCCESSFULLY USING PERITONEAL DIALYSIS CATHETER UNTIL HE NOTICED THAT ONE PIECE WAS LOOSE & THE REST WAS IN HIS ABDOMEN. HE WAS ADMITTED TO THE HOSP FOR STABILIZATION OF RENAL & CARDIAC STATUS IN PREPARATION FOR SURGICAL REMOVAL OF THE RETAINED DEVICE FRAGMENT. A SUBCLAVIAN HEMODIALYSIS CATH WAS PLACED 5/19. THE P.D. CATH WAS REMOVED 5/21. REPLACEMENT IS SCHEDULED FOR 6/10/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE COIL CATHETER Implant PERITONEAL DIALYSIS CATHETER FJS LIFE MED OF CALIFORNIA * L9H003

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization