BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENCKHOFF CHRONIC PERITONEAL CATHETER

    MDR report key: 36731 · Received August 30, 1996

    Report

    Report Number
    2018692-1996-00001
    Event Type
    Injury
    Date Received
    August 30, 1996
    Date of Event
    June 4, 1996
    Report Date
    August 7, 1996
    Manufacturer
    LIFEMED OF CALIFORNIA
    Product Code
    FJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO GIVEN IN SECTION F WAS OBTAINED FROM CO RECORDS. CO HAS SOLICITED THE INFO FROM THE CONTACT PERSON BY LETTER, PHONE AND FAX. CO HAS RECEIVED NO MORE INFO FROM CONTACT.

    Description of Event or Problem · 1

    EXTERNAL INFECTION OCCURRING AT THE SITE OF THE SUBCUTANEOUS CUFF OF THE PERITONEAL CATHETER WAS TREATED BY EXCISING THE UNFECTED SKIN. THE CUFF WAS FREED FROM THE SKIN AND THE BULK OF THE CUFF MATERIAL WAS REMOVED. THE CATHETER WAS ANCHORED TO THE INTACT AREA OF THE SKIN WITH NYLON SUTURES. PRIOR TREATMENT OF THE INFECTION WITH ANTIBIOTICS AND CLEANSING THE SITE DID NOT ELIMINATE THE INFECTION, WHICH BECAME CHRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENCKHOFF CHRONIC PERITONEAL CATHETER Implant PERITONEAL CATHETER FJS LIFEMED OF CALIFORNIA NA L3D029

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R