BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PERITONEAL DIALYSIS

    MDR report key: 8146873 · Received December 10, 2018

    Report

    Report Number
    3009211636-2018-00386
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    April 1, 2013
    Report Date
    December 10, 2018
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: COMPARISON WITH THE CONVENTIONAL FAN PEELED CATHETERIZATION EFFECTS OF PERITONEAL DIALYSIS CATHETER SOURCE CHINA BLOOD PURIFICATION, VOLUME 12, 2013(180-183). ARTICLE NUMBER: 4. DATE OF PUBLICATION: APRIL, 2013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM FEBRUARY 2009 TO APRIL 2012, DURING USE WITH ISSUES INCLUDING CATHETER LEAK, CATHETER MIGRATION, EXIT SITE INFECTION, PERITONITIS, CATHETER OCCLUSION/DYSFUNCTION. THE DEVICES WERE USED FOR TREATMENT RENAL REPLACEMENT THERAPY. ONE CASE USING IMPROVED METHOD HAD CATHETER LEAK ISSUE, AND THE MEDICAL RECORDS WERE REVIEWED. THE PATIENT WITH OBVIOUS WEIGHT LOSS AND A THIN PERITONEUM. WHEN THE FAN-SHAPED OPENER WAS APPLIED INTO THE PERITONEAL INCISION, THE INCISION WAS ENLARGED, AND THE ABDOMINAL MUSCLES WERE THIN, LEADING TO LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986955 UNKNOWN PERITONEAL DIALYSIS CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. UNKNOWN PERITONEAL DIALYSIS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention