BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMINO NEURO CARE COMPLETE ICP MONITOR KIT

    MDR report key: 105496 · Received July 1, 1997

    Report

    Report Number
    105496
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    May 31, 1997
    Report Date
    June 2, 1997
    Manufacturer
    NEUROCARE GROUP CAMINO NEURO CARE INC. HEYER-SCHULTE NEUROCARE, L.P.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ICP FIBEROPTIC MONITORING PROBE - INSERTED ON 5/29/97. ON 5/31/97 PT IN BED WITH HEAD AGAINST SIDE RAIL - BOLT FOUND TO BE BROKEN AT HUB. ICP REMOVED AND NEW ICP INSERTED BY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMINO NEURO CARE COMPLETE ICP MONITOR KIT Implant FIBEROPTIC MONITORING PROBE JXG NEUROCARE GROUP CAMINO NEURO CARE INC. HEYER-SCHULTE NEUROCARE, L.P. 110-4BC *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention