BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMINO

    MDR report key: 45271 · Received October 29, 1996

    Report

    Report Number
    2023988-1996-00006
    Event Type
    Injury
    Date Received
    October 29, 1996
    Date of Event
    September 1, 1996
    Manufacturer
    CAMINO NEUROCARE, INC
    Product Code
    HCA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED ON 8-25-96 WITH A SUB-ARACHNOID HEMORRHAGE SECONDARY TO A RUPTURED ANEURYSM. ANGIOGRAM ALSO SHOWED AN UNRUPTURED RIGHT MIDDLE COMMUNICATING ARTERY ANEURYSM. PATIENT UNDERWENT A CRANIOTOMY AND CLIPPING OF BOTH ANEURYSMS. ON 8-26-96 VENTRICULOSTOMY WAS PERFORMED. ON 8-27-96, AN EMERGENCY CRANIOTOMY WAS DONE WITH DECOMPRESSION AND RIGHT TEMPORAL LOBECTOMY. ON 9-1-96, CEREBRAL SPINAL FLUID CULTURE WAS POSITIVE FOR NUMEROUS STAPHYLOCOCCUS AUREUS AND MODERATE STAPHYLOCOCCUS EPIDERMIS. PATIENT'S MENINGITIS WAS TREATED WITH CEFTIZOXIME, NAFCILLIN AND RIFAMPIN. ON 9-2-96 LEAKAGE WAS NOTED AT THE VENTRICULOSTOMY CATHETER SITE. ON 9-7-96, A TRACHEOSTOMY AND J-TUBE WERE PLACED. ON 9-8-96, VENTRICULOSTOMY WAS REMOVED. ON 9-11-96, THE CEREBROSPINAL FLUID CULTURE SHOWED NO GROWTH X4 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMINO VENTRIX-VENTRICULAR DRAINAGE SYSTEM HCA CAMINO NEUROCARE, INC NL950-VC *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization