BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUINTON TENCKHOFF PERITONEAL CATHETER

    MDR report key: 203558 · Received December 21, 1998

    Report

    Report Number
    3014398-1998-01004
    Event Type
    Injury
    Date Received
    December 21, 1998
    Date of Event
    April 17, 1995
    Report Date
    December 14, 1998
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    FJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D ALLEGING THAT PT'S PERITONEAL CATHETER WAS EXPLANTED INCORRECTLY ON 04/17/1995 RESULTING IN SUBSEQUENT REOPENING OF WOUND AND BLEEDING FROM EXIT SITE. PT ALLEGES THAT IMPROPER EXPLANT ALSO RESULTED IN NUMEROUS INTERNAL AND EXTERNAL INFECTIONS. PT WAS ADMITTED TO THE ER ON 12/20/1996 AND EXPLORATORY SURGERY REVEALED THAT "A FRACTURED PIECE OF THE CUFF OF A TENCKHOFF CATHETER" HAD BEEN LEFT IN THE EXIT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUINTON TENCKHOFF PERITONEAL CATHETER Implant PERITONEAL DIALYSIS CATHETER FJS QUINTON INSTRUMENT CO. 10888-003 409652

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R