BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMINO NEURO CARE, INC.

    MDR report key: 107786 · Received June 30, 1997

    Report

    Report Number
    107786
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Date of Event
    April 14, 1997
    Report Date
    April 25, 1997
    Manufacturer
    CAMINO LABORATORIES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HARTFORD HOSP SUBMITS THIS REPORT PURSUANT TO 21CFR803. IT IS BASED ON INFO REVIEWED BY HARTFORD HOSP WHICH IT MAY NOT HAVE HAD AN OPPORTUNITY TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE REPORTING DATE. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY HARTFORD HOSP THAT IT OR ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED. A CAMINO ICP BOLT WAS INSERTED TO MONITOR PRESSURE. PT NOTED TO HAVE NEGATIVE PRESSURES AFTER A TRANSPORT TO X-RAY. RESIDENT FOUND CRACK IN PROTECTIVE SHIELD (NOT SAVED). CATHETER WAS REPLACED AND CONTINUED TO HAVE NEGATIVE PRESSURE READINGS. SECOND CATHETER REMOVED AND ALSO FOUND TO HAVE A LARGE CRACK IN SHEATH. EXACT LOT # NOT KNOWN AS THERE ARE MORE THAN ONE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMINO NEURO CARE, INC. INTRACRANIAL PRESSURE TRANSDUCER STRAIN RELIEF SHEATH GWM CAMINO LABORATORIES 110-4B *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other