BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVERTIBLE ADAPTER 4 INCH EXTENSION

    MDR report key: 321205 · Received March 16, 2001

    Report

    Report Number
    8030665-2001-00009
    Event Type
    Injury
    Date Received
    March 16, 2001
    Date of Event
    January 17, 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

    FACILITY REPORTS EXTENSION SET LEAKS. PT GIVEN CEFTAZIDINE 1400MG IP X 3 DAYS THEN ANCEF 1400MG IP X 17 DAYS. NO SAMPLE AVAILABLE FOR ANALYSIS. CULTURE AND SENSITIVITY INDICATE STAPHYLOCOCCUS COAGULASE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11830 CONVERTIBLE ADAPTER 4 INCH EXTENSION PERITONEAL DIALYSIS DEVICE KDJ ERIKA DE REYNOSA NA 0DR812

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R