BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVERTIBLE ADAPTER 4 INCH EXTENSION

    MDR report key: 321700 · Received March 16, 2001

    Report

    Report Number
    8030665-2001-00011
    Event Type
    Injury
    Date Received
    March 16, 2001
    Date of Event
    January 16, 2001
    Report Date
    February 28, 2001
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    KDJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CANADIAN REFERENCE # - 1292. FACILITY REPORTS THAT EXTENSION SET LEAKS. PT DEVELOPED PERITONITIS, TREATED WITH ANCEF 2000MG AND GENTAMYCIN 32MG IP X 3 DAYS THEN VANCOMYCIN 2,500MG IP X 3 WEEKS. SAMPLE NOT AVAILABLE FOR ANALYSIS. CULTURE AND SENSITIVITY INDICATE - STAPHYLOCOCCUS COAGULASE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11805 CONVERTIBLE ADAPTER 4 INCH EXTENSION PERITONEAL DIALYSIS DEVICE KDJ ERIKA DE REYNOSA NA 0DR812

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R