BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2241778 · Received September 9, 2011

    Report

    Report Number
    1226348-2011-00339
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    May 31, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT AFTER THE PATIENT HAD BEEN TURNED AND HAD THEIR BED MADE THE HOSPITAL FOUND THE PATIENTS ICP COULD NOT BE MEASURED. UPON FURTHER INSPECTION FROM THE HOSPITAL STAFF IT APPEARED THAT THE WIRE WAS EXPOSED IN ONE AREA AND MELTED IN ANOTHER AREA. PLEASE NOTE THAT THE ALERT DATE AS WELL AS THE EVENT DATE MAY BE IN ACCURATE. MORE INFORMATION IS EXPECTED AND WILL BE REPORTED IN THE FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN AND SHURTLEFF - MEDOS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention